ATTEST: Atrial Fibrillation Progression Trial

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01570361
• Collaborator: (none)
• Enrollment: 255
• Locations: 36
• Arms: 2
• Actual Duration (Months): 82.2
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Catheter Ablation; Drug: Drug Treatment	Phase 4

Detailed Description

Eligible PAF subjects with recurrent AF for 2 years who have failed no more than 2 prescribed drugs (with either anti-arrhythmic or rate control drug) are randomized into one of two study arms (catheter ablation or drug therapy).

Study Design

• Study Type: Interventional
• Actual Enrollment: 255 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Atrial Fibrillation Progression Trial
• Actual Study Start Date: Feb 13, 2012
• Actual Primary Completion Date: Dec 19, 2018
• Actual Study Completion Date: Dec 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Catheter Ablation Radiofrequency catheter ablation treatment in subjects with Paroxysmal Atrial Fibrillation (PAF)	Device: Catheter Ablation; Treat subjects with Paroxysmal Atrial Fibrillation (PAF); Other Names: CARTO® 3 or CARTO® XP System and THERMOCOOL® Catheter Family
Active Comparator: Drug Treatment Drug therapy (either rate or rhythm control) using current AF management guidelines	Drug: Drug Treatment; Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.; Other Names: Antiarrhythmic Drugs

Outcome Measures

Primary Outcome Measures

1. Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years [3 years]

   Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

Secondary Outcome Measures

1. Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year [1 year]

   Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

2. Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years [2 years]

   Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

3. Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year [1 year]

   Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

4. Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years [2 Years]

   Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

5. Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year [3 year]

   Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

6. Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations [3 years]

   Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

7. Number of Repeat Ablations [3 years]

   Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is >= 2, then subject had at least one repeat procedure.

8. Number of New Antiarrhythmic Drugs [3 years]

   Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines.

9. Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up [3 months, 6 months, 1 year, 2 years, 3 years]

   Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit

10. Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up [3 months, 6 months, 1 year, 2 year and 3 years]

    Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" )

2. HATCH Score of at least ≥1 and ≤4.

3. Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).

4. Age 60 years or older.

5. Left atrium (LA) diameter ≤ 55mm by TTE.

6. Left ventricle (LV) ejection fraction ≥50% when in sinus rhythm or LV ejection fraction ≥35% when in atrial fibrillation.

NOTE: For patients entering the study in AF with an ejection fraction ≥35% and <50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is >50% the subject can continue in the study.

1. Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing.

Exclusion Criteria:

1. Patients awaiting cardiac transplantation or other cardiac surgery.

2. Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study.

3. Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc.

4. Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months.

5. Heart failure decompensation.

6. Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter.

7. Previously required cardioversion >48 hours after onset of atrial fibrillation/ atrial flutter.

8. Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery.

9. Pulmonary embolism or recent atrial embolism/thrombosis.

10. Hypertrophic obstructive cardiomyopathy.

11. Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation).

12. Mandated anti-arrhythmic drug therapy for disease conditions other than atrial fibrillation.

13. Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.

14. Prior left atrial catheter ablation with the intention of treating atrial fibrillation; prior surgical interventions for AF such as the MAZE procedure.

15. Prior AV nodal ablation.

16. Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use.

17. Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications.

18. Medical conditions limiting expected survival to <3 years.

19. Concurrent participation in any other clinical study.

20. Prior history of non-adherence to prescribed drug regimens.

21. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial

NOTE: Prior ablation of the cavo-tricuspid isthmus is not a reason to exclude, if the patient develops subsequent recurrent atrial fibrillation.

NOTE: For patients randomized to the PVI group (Test Group), a Transesophageal Echocardiography (TEE) should be performed (as per standard of care), within 48 hours pre-procedure, to exclude atrial thrombus or other structural contraindications for an ablation procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Adelaide Hospital	Adelaide		Australia	5000
2	Medizinische Universitaetsklinik	Graz		Austria	8036
3	Krankenhaus der Elisabethinen	Linz		Austria	4020
4	OLV Ziekenhuis	Aalst		Belgium	9300
5	AZ Sint Jan	Brugge		Belgium	8000
6	Kerckhoff Klinik	Bad Nauheim		Germany	61231
7	Vivantes Klinikum am Urban	Berlin		Germany	10967
8	Helios Klinikum Berlin-Buch	Berlin		Germany	13125
9	Herzzentrum Universitätsmedizin Göttingen	Göttingen		Germany	37099
10	Asklepios Klinik St. Georg	Hamburg		Germany	20099
11	University Heart Center Hamburg-Eppendorf	Hamburg		Germany	20246
12	Herzpraxis Altona	Hamburg		Germany	22765
13	Semmelweis University, Cardiovascular Center	Budapest		Hungary	1122
14	Mater Misericordiae University Hospital	Dublin		Ireland	7
15	Ospedale Generale Regionale "F. Miulli"	Bari		Italy	70021
16	Ospedaleria Universitaria Pisana	Pisa		Italy	56126
17	Policlinico Casalino Roma	Roma		Italy	00169
18	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
19	Asan Medical Center	Seoul		Korea, Republic of	05505
20	Samsung Medical Center	Seoul		Korea, Republic of	06351
21	P. Stradins Clinical University Hospital	Riga		Latvia	1002
22	Haukeland Universitetssykehus	Bergen		Norway	5021
23	Cardinal Stefan Wyszyński Institute of Cardiology	Warszaw		Poland	04-628
24	Federal Center of Cardiovascular Surgery	Krasnoyarsk		Russian Federation	45
25	Federal State Institution National Research Center for Preventive Medicine of Healthcare of the Russian Federation	Moscow		Russian Federation	101990
26	State Research Institute of Circulation Pathology	Novosibirsk		Russian Federation	55
27	Almazov Federal Heart, Blood and Endocrinology Centre	Saint-Petersburg		Russian Federation	194341
28	Federal State Budgetary Scientific Institution "Research Institute for Cardiology"	Tomsk		Russian Federation	634012
29	Hospital Universitario Infanta Leonor	Madrid		Spain	28007
30	Hospital General Universitario Gregorio Maranon	Madrid		Spain	28009
31	Hospital Universitario Virgen de la Victoria	Malaga		Spain	29010
32	Hospital Universitario Salamanca	Salamanca		Spain	37007
33	Universitetssjukhuset Örebro	Örebro		Sweden	701 85
34	Royal Bournemouth Hospital	Bournemouth		United Kingdom	BH7 7DW
35	Papworth Hospital	Cambridge		United Kingdom	CB23 3RE
36	University Hospital of South Manchester	Manchester		United Kingdom	M23 9LT

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

• Principal Investigator: Karl-Heinz Kuck, MD, Asklepios Klinik St. Georg

Study Documents (Full-Text)

• Statistical Analysis Plan - Nov 8, 2018
• Study Protocol - Apr 9, 2013

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT01570361
• Other Study ID Numbers: ATTEST
• First Posted: Apr 4, 2012
• Last Update Posted: May 14, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Biosense Webster, Inc.: Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes
• Additional relevant MeSH terms: Atrial Fibrillation; Anti-Arrhythmia Agents

Study Results

Participant Flow

Recruitment Details	The first subject was enrolled on 13-Feb-2012. On 27-Feb-2018, study was terminated early due to enrollment not proceeding in accordance with expectations, independently from the study outcome. The last subject completed the last visit on 29-May-2018.
Pre-assignment Detail	Before randomization and signing inform consent forms, all subjects were screened according protocol defined inclusion and exclusion criteria. Screening failures were excluded from the study and were not randomized.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Period Title: Overall Study
STARTED	128	127
Received Study Treatment	102	123
Cross-over (AAD Therapy to RF Ablation)	0	15
AAD Therapy Only	0	108
COMPLETED	46	52
NOT COMPLETED	82	75

Baseline Characteristics

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy	Total
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).	Total of all reporting groups
Overall Participants	128	127	255
Age (Year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Year]	67.8 (4.83)	67.6 (4.64)	67.7 (4.73)
Sex: Female, Male (Count of Participants)
Female	74 57.8%	74 58.3%	148 58%
Male	54 42.2%	53 41.7%	107 42%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years
Description	Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Measure Participants	128	127
Median (95% Confidence Interval) [Months]	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Radiofrequency (RF) Ablation Treatment, Antiarrhythmic Drug (AAD) Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0009
	Comments	Prior to the final analysis, study had two interim analyses. Hence alpha level is 0.0231 for primary analysis adjusted for the two interim analyses.
	Method	Log Rank
	Comments	One-sided test

2. Secondary Outcome

Title	Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Description	Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Measure Participants	128	127
Median (95% Confidence Interval) [Months]	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Radiofrequency (RF) Ablation Treatment, Antiarrhythmic Drug (AAD) Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0118
	Comments	The alpha level is 0.025 for this secondary endpoint.
	Method	Log Rank
	Comments	One-sided test

3. Secondary Outcome

Title	Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Description	Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Measure Participants	128	127
Median (95% Confidence Interval) [Months]	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Radiofrequency (RF) Ablation Treatment, Antiarrhythmic Drug (AAD) Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0041
	Comments	The alpha level is 0.025 for this secondary endpoint.
	Method	Log Rank
	Comments	One-sided test

4. Secondary Outcome

Title	Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Description	Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Measure Participants	128	127
Number (95% Confidence Interval) [Percentage of Participants]	1.3 1%	6.5 5.1%

5. Secondary Outcome

Title	Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Description	Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Measure Participants	128	127
Number (95% Confidence Interval) [Percentage of participants]	2.4 1.9%	12.4 9.8%

6. Secondary Outcome

Title	Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year
Description	Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Measure Participants	128	127
Number (95% Confidence Interval) [Percentage of Participants]	2.4 1.9%	17.5 13.8%

7. Secondary Outcome

Title	Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations
Description	Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Endpoint applicable only to subjects randomized into the test group.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
Measure Participants	128
Number of ablations = 0	0.0 0%
Number of ablations = 1	1.5 1.2%
2 or more ablations	7.7 6%

8. Secondary Outcome

Title	Number of Repeat Ablations
Description	Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is >= 2, then subject had at least one repeat procedure.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Subjects in the Intent to treat population (ITT) who were randomized to RF ablation or who received any RF ablations as Cross-Over Patients randomized to AAD group. ITT population includes all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Radiofrequency (RF) Ablation 2nd Treatment
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Participants who were initially treated with AAD therapy (1st treatment) and then crossed over to RF ablation (2nd treatment) were evaluated. AAD therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.
Measure Participants	128	15
Mean (Standard Deviation) [Event of ablation]	0.9 (0.57)	1.1 (0.26)

9. Secondary Outcome

Title	Number of New Antiarrhythmic Drugs
Description	Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Measure Participants	128	127
Mean (Standard Deviation) [AAD drug]	0.8 (1.05)	1.0 (1.23)

10. Secondary Outcome

Title	Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up
Description	Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit
Time Frame	3 months, 6 months, 1 year, 2 years, 3 years

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. The number of participants analyzed at each visit is the number of participants with available data at the visit.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Measure Participants	128	127
3 month follow up	51 39.8%	55 43.3%
6 month follow up	49 38.3%	42 33.1%
1 year follow up	41 32%	35 27.6%
2 year follow up	37 28.9%	30 23.6%
3 year follow up	20 15.6%	23 18.1%

11. Secondary Outcome

Title	Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up
Description	Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit
Time Frame	3 months, 6 months, 1 year, 2 year and 3 years

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. The number of participants analyzed at each visit is the number of participants with available data at the visit.

Arm/Group Title	Radiofrequency (RF) Ablation Treatment	Antiarrhythmic Drug (AAD) Therapy
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).	Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
Measure Participants	128	127
3 month follow up	17 13.3%	20 15.7%
6 month follow up	17 13.3%	45 35.4%
1 year follow up	20 15.6%	38 29.9%
2 year follow up	16 12.5%	30 23.6%
3 year follow up	10 7.8%	17 13.4%

Adverse Events

Time Frame	3 years follow up
Adverse Event Reporting Description	Adverse events are summarized using the Safety population, which includes all subjects who had undergone insertion of an ablation catheter, either as RF ablation group or cross-over subjects; subjects who had started an investigator prescribed AAD in the AAD Group and did not initiate ablation therapy.
Arm/Group Title	Radiofrequency (RF) Ablation Treatment		Antiarrhythmic Drug (AAD) Therapy Only		Antiarrhythmic Drug (AAD) Therapy - First Treatment		Radiofrequency (RF) Ablation - Second Treatment
Arm/Group Description	Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).		Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. This group includes only those subjects received AAD only.		This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the AAD treatment period.		This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the RF treatment period.
All Cause Mortality
	Radiofrequency (RF) Ablation Treatment		Antiarrhythmic Drug (AAD) Therapy Only		Antiarrhythmic Drug (AAD) Therapy - First Treatment		Radiofrequency (RF) Ablation - Second Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/102 (4.9%)		4/108 (3.7%)		0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Radiofrequency (RF) Ablation Treatment		Antiarrhythmic Drug (AAD) Therapy Only		Antiarrhythmic Drug (AAD) Therapy - First Treatment		Radiofrequency (RF) Ablation - Second Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/102 (37.3%)		30/108 (27.8%)		7/15 (46.7%)		4/15 (26.7%)
Blood and lymphatic system disorders
Anaemia	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Cardiac disorders
Acute coronary syndrome	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Angina unstable	0/102 (0%)	0	0/108 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Arrhythmia	1/102 (1%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Atrial fibrillation	8/102 (7.8%)	13	7/108 (6.5%)	9	4/15 (26.7%)	4	3/15 (20%)	4
Atrial flutter	4/102 (3.9%)	4	2/108 (1.9%)	2	0/15 (0%)	0	0/15 (0%)	0
Atrial tachycardia	1/102 (1%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Bradycardia	4/102 (3.9%)	5	2/108 (1.9%)	2	0/15 (0%)	0	0/15 (0%)	0
Cardiac arrest	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Cardiac failure congestive	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Cardiac tamponade	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Coronary artery stenosis	1/102 (1%)	1	1/108 (0.9%)	1	1/15 (6.7%)	1	0/15 (0%)	0
Intracardiac thrombus	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Myocardial infarction	1/102 (1%)	1	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Palpitations	1/102 (1%)	1	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Pericardial effusion	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Pericarditis	2/102 (2%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Sinus bradycardia	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Sinus node dysfunction	1/102 (1%)	1	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Tachyarrhythmia	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Tachycardia	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Ventricular tachyarrhythmia	2/102 (2%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Eye disorders
Eyelid oedema	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Gastrointestinal disorders
Chronic gastritis	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Constipation	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Diarrhoea	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Faeces discoloured	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Haematemesis	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Ileus	0/102 (0%)	0	0/108 (0%)	0	0/15 (0%)	0	1/15 (6.7%)	1
Inguinal hernia	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Melaena	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Pancreatic pseudocyst	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Proctalgia	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
General disorders
Chest pain	3/102 (2.9%)	3	2/108 (1.9%)	2	0/15 (0%)	0	0/15 (0%)	0
Inflammation	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Hepatobiliary disorders
Bile duct stenosis	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Cholangitis	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Cholecystitis	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Cholecystitis acute	0/102 (0%)	0	2/108 (1.9%)	2	0/15 (0%)	0	0/15 (0%)	0
Cholelithiasis	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Infections and infestations
Perineal abscess	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Pneumonia	1/102 (1%)	1	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Prostate infection	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Pyelonephritis	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Injury, poisoning and procedural complications
Acetabulum fracture	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Road traffic accident	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Subarachnoid haemorrhage	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Upper limb fracture	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Vascular pseudoaneurysm	1/102 (1%)	3	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Investigations
Arteriogram coronary	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Back pain	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Haemarthrosis	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Osteoarthritis	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Bronchial carcinoma	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Lung neoplasm malignant	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Malignant melanoma	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Neoplasm malignant	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Pancreatic carcinoma	1/102 (1%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Prostate cancer	1/102 (1%)	1	1/108 (0.9%)	2	0/15 (0%)	0	0/15 (0%)	0
Prostate cancer recurrent	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Uterine cancer	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Nervous system disorders
Cerebrovascular accident	1/102 (1%)	1	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Dizziness postural	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Nerve degeneration	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Radicular syndrome	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Syncope	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Product Issues
Device lead damage	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Device occlusion	1/102 (1%)	3	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Psychiatric disorders
Major depression	1/102 (1%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Renal and urinary disorders
Urinary retention	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Reproductive system and breast disorders
Pelvic prolapse	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Dyspnoea	0/102 (0%)	0	1/108 (0.9%)	1	1/15 (6.7%)	1	0/15 (0%)	0
Epistaxis	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Lung disorder	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Pulmonary oedema	2/102 (2%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Respiratory failure	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Sleep apnoea syndrome	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Surgical and medical procedures
Abscess drainage	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Cardiac ablation	0/102 (0%)	0	0/108 (0%)	0	0/15 (0%)	0	1/15 (6.7%)	1
Hernia repair	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Vascular disorders
Arteriovenous fistula	1/102 (1%)	1	1/108 (0.9%)	3	0/15 (0%)	0	0/15 (0%)	0
Haematoma	2/102 (2%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Haemorrhage	2/102 (2%)	2	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Hypertension	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Hypertensive emergency	1/102 (1%)	1	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Thrombosis	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Other (Not Including Serious) Adverse Events
	Radiofrequency (RF) Ablation Treatment		Antiarrhythmic Drug (AAD) Therapy Only		Antiarrhythmic Drug (AAD) Therapy - First Treatment		Radiofrequency (RF) Ablation - Second Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/102 (36.3%)		43/108 (39.8%)		6/15 (40%)		4/15 (26.7%)
Cardiac disorders
Angina pectoris	0/102 (0%)	0	0/108 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Aortic valve incompetence	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Atrial fibrillation	13/102 (12.7%)	14	20/108 (18.5%)	22	2/15 (13.3%)	2	1/15 (6.7%)	2
Atrial flutter	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Atrial thrombosis	1/102 (1%)	1	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Bradycardia	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Cardiac failure	0/102 (0%)	0	3/108 (2.8%)	3	0/15 (0%)	0	0/15 (0%)	0
Cardiac failure chronic	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Cardiac failure congestive	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Cardiac valve disease	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Coronary artery stenosis	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Pericardial effusion	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Supraventricular extrasystoles	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Supraventricular tachycardia	1/102 (1%)	1	0/108 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Tachycardia	2/102 (2%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Ear and labyrinth disorders
Deafness	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Vertigo	0/102 (0%)	0	1/108 (0.9%)	1	1/15 (6.7%)	1	1/15 (6.7%)	1
Endocrine disorders
Thyroid disorder	2/102 (2%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Eye disorders
Dry eye	0/102 (0%)	0	0/108 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Constipation	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Diarrhoea	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Dry mouth	0/102 (0%)	0	0/108 (0%)	0	2/15 (13.3%)	2	0/15 (0%)	0
Gastrooesophageal reflux disease	1/102 (1%)	1	1/108 (0.9%)	1	1/15 (6.7%)	1	0/15 (0%)	0
Large intestine polyp	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Nausea	1/102 (1%)	1	1/108 (0.9%)	1	0/15 (0%)	0	1/15 (6.7%)	1
Proctalgia	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
General disorders
Chest pain	2/102 (2%)	2	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Fatigue	2/102 (2%)	2	2/108 (1.9%)	2	0/15 (0%)	0	0/15 (0%)	0
Non-cardiac chest pain	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Oedema peripheral	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Pyrexia	2/102 (2%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Vessel puncture site pain	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Immune system disorders
Anaphylactic shock	2/102 (2%)	2	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Infections and infestations
Bronchitis	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Conjunctivitis bacterial	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Influenza	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Pneumonia	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Respiratory tract infection	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Systemic infection	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Upper respiratory tract infection	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Viral upper respiratory tract infection	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Injury, poisoning and procedural complications
Foot fracture	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Lower limb fracture	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Rib fracture	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Upper limb fracture	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Vascular pseudoaneurysm	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Investigations
Body temperature increased	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Electrocardiogram change	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Heart rate irregular	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Prostatic specific antigen increased	1/102 (1%)	1	1/108 (0.9%)	2	0/15 (0%)	0	0/15 (0%)	0
Metabolism and nutrition disorders
Hyperlipidaemia	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Type 2 diabetes mellitus	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Musculoskeletal and connective tissue disorders
Bursitis	0/102 (0%)	0	0/108 (0%)	0	1/15 (6.7%)	1	0/15 (0%)	0
Nervous system disorders
Cerebral ischaemia	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Neuralgia	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Restless legs syndrome	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Syncope	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Psychiatric disorders
Depression	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Renal and urinary disorders
Dysuria	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Haematuria	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Reproductive system and breast disorders
Prostatic disorder	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/102 (1%)	1	5/108 (4.6%)	5	0/15 (0%)	0	1/15 (6.7%)	1
Bronchospasm	0/102 (0%)	0	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Vascular disorders
Haematoma	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Haemorrhage	1/102 (1%)	1	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0
Hypertension	1/102 (1%)	1	2/108 (1.9%)	2	0/15 (0%)	0	0/15 (0%)	0
Hypertensive crisis	1/102 (1%)	1	2/108 (1.9%)	2	0/15 (0%)	0	0/15 (0%)	0
Hypertensive emergency	1/102 (1%)	1	0/108 (0%)	0	0/15 (0%)	0	0/15 (0%)	0
Hypotension	2/102 (2%)	2	1/108 (0.9%)	1	0/15 (0%)	0	0/15 (0%)	0

Limitations/Caveats

As the study was terminated early without having met primary effectiveness or futility criteria, the study results should be interpreted with caution.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.