CAP-AF: Continued Access Protocol

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00889681
• Collaborator: Medtronic (Industry)
• Enrollment: 81
• Locations: 10
• Arm: 1
• Duration (Months): 55
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Arctic Front Cardiac Cryoablation System	N/A

Detailed Description

1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures-Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

2. To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

3. To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Ablation All study subjects will be receive cryo ablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.

Device: Arctic Front Cardiac Cryoablation System; The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation.; Other Names: Arctic Front® Catheter Ref# 2AF232 & 2AF282 Manual Retraction Kit Ref# 20MRK Freezor MAX Catheter Ref # 239F3 & 239F5 Console Ref # 106A2

Outcome Measures

Primary Outcome Measures

1. Cryoablation Procedure Events (CPEs) [365 days]

   Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.

2. Acute Procedural Success (APS) [At the conclusion of the cryoablation procedure]

   Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.

3. Freedom From Major Atrial Fibrillation Events (MAFE) [365 days]

   Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.

4. Long-term Clinical Success [180 days]

   Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects must fulfill ALL of the following criteria:

1. Documented PAF:

• diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND

• 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing

1. 18 and 75 years of age

2. Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.

Exclusion Criteria:

ANY of the following is regarded as a criterion for excluding a subject from the study:

1. Any previous left atrial (LA) ablation (except permissible retreatment subjects)

2. Any previous LA surgery

3. Current intracardiac thrombus (can be treated after thrombus is resolved)

4. Presence of any pulmonary vein stents

5. Presence of any pre-existing pulmonary vein stenosis

6. Pre-existing hemidiaphragmatic paralysis

7. Anteroposterior LA diameter > 5.5 cm by TTE

8. Presence of any cardiac valve prosthesis

9. Clinically significant mitral valve regurgitation or stenosis

10. Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date

11. Unstable angina

12. Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date

13. Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)

14. NYHA class III or IV congestive heart failure

15. Left ventricular ejection fraction (LVEF) < 40%

16. 2º (Type II) or 3º atrioventricular block

17. Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)

18. Brugada syndrome

19. Long QT syndrome

20. Arrhythmogenic right ventricular dysplasia

21. Sarcoidosis

22. Hypertrophic cardiomyopathy

23. Known cryoglobulinemia

24. Uncontrolled hyperthyroidism

25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.

26. Any woman known to be pregnant

27. Any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:

• negative β-HCG test within 7 days prior to Start Date

• history of surgical sterilization

• postmenopausal and free of menses for at least 12 months.

1. Life expectancy less than one (1) year

2. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study

3. Unwilling or unable to comply fully with study procedures and follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Good Samaritan	Phoenix	Arizona	United States	85006
2	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
3	Stanford Hospital & Clinical	Stanford	California	United States	94305-5288
4	Bay Heart Group	Tampa	Florida	United States	33607
5	Piedmont Hospital	Atlanta	Georgia	United States	30309
6	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
7	Mayo Clinic	Rochester	Minnesota	United States	55905
8	Baylor Heart & Vascular Hospital	Dallas	Texas	United States	75226
9	Inova Research Center	Falls Church	Virginia	United States	22042
10	Virginia Commonwealth University Health System	Richmond	Virginia	United States	23219

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure
• Medtronic

Investigators

• Principal Investigator: Douglas Packer, MD, Mayo Clinic, Rochester, MN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT00889681
• Other Study ID Numbers: CAP PS-024
• First Posted: Apr 29, 2009
• Last Update Posted: Sep 19, 2018
• Last Verified: Sep 1, 2018

• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details	Investigators at ten (10) sites enrolled a total of 81 study subjects between March 31, 2009 and January 24, 2011. The first subject was cryoablated on April 3, 2009.
Pre-assignment Detail	There were three (3) subjects who were early exits in the study, two for not meeting qualification criteria and one for insurance disapproval.

Arm/Group Title	Enrolled for Cryoablation Treatment
Arm/Group Description	All patients that signed the informed consent were considered enrolled. Patients enrolled in the study received cryoablation treatment for paroxysmal atrial fibrillation.
Period Title: Overall Study
STARTED	81
Received Treatment	78
COMPLETED	78
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Enrolled for Cryoablation Treatment
Arm/Group Description	All patients that signed the informed consent were considered enrolled. Patients enrolled in the study to receive cryoablation treatment for paroxysmal atrial fibrillation.
Overall Participants	81
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	56 69.1%
>=65 years	25 30.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.7 (10.4)
Sex: Female, Male (Count of Participants)
Female	22 27.2%
Male	59 72.8%
Region of Enrollment (participants) [Number]
United States	81 100%

Outcome Measures

1. Primary Outcome

Title	Cryoablation Procedure Events (CPEs)
Description	Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

78 of the 81 enrolled subjects were treated with cryoablation.

Arm/Group Title	Treated With Cryoablation
Arm/Group Description	Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
Measure Participants	78
One or more CPE (all types)	1 1.2%
CPE type: Access site complications	0 0%
CPE type: Cardiac damage (including MI)	0 0%
CPE type: Embolic phenomena (including stroke)	0 0%
CPE type: Arrhythmias	1 1.2%
CPE type: Persistent phrenic nerve injury	0 0%
CPE type: Death	0 0%
CPE type: Pulmonary vein stenosis	0 0%

2. Primary Outcome

Title	Acute Procedural Success (APS)
Description	Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
Time Frame	At the conclusion of the cryoablation procedure

Outcome Measure Data

Analysis Population Description

78 of 81 subjects were treated with cryoablation.

Arm/Group Title	Treated With Cryoablation
Arm/Group Description	Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
Measure Participants	78
Number [Participants]	75 92.6%

3. Primary Outcome

Title	Freedom From Major Atrial Fibrillation Events (MAFE)
Description	Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

78 of 81 enrolled subjects were treated with cryoablation.

Arm/Group Title	Treated With Cryoablation
Arm/Group Description	Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
Measure Participants	78
Freedom from any MAFE (all types)	74 91.4%
One or more MAFE (all types)	4 4.9%
MAFE type: Cardvascular death	0 0%
MAFE type: Hosp for AF recurrence or ablation	2 2.5%
MAFE type: Hosp for A flutter ablation (ex Type I)	0 0%
MAFE type: Hosp for systemic embolism (not stroke)	0 0%
MAFE type: Hosp for congestive heart failure	0 0%
MAFE type: Hosp for hemorrhagic event (not stroke)	2 2.5%
MAFE type: Antiarrhythmic medication	1 1.2%
MAFE type: Myocardial infarction	0 0%
MAFE type: Stroke	0 0%

4. Primary Outcome

Title	Long-term Clinical Success
Description	Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

78 of 81 subjects were treated with cryoablation.

Arm/Group Title	Treated With Cryoablation
Arm/Group Description	Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
Measure Participants	78
Number [Participants]	51 63%

Adverse Events

Time Frame	From time of consent to study exit (mean follow up time 3.4 years)
Adverse Event Reporting Description	Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization >48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Arm/Group Title	Treated With Cryoablation
Arm/Group Description	This study is a single arm, non-randomized controlled study of patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of AF ("Atrial Fibrillation Drugs " or AFDs). All study subjects will be receiving cryoablation with the experimental devices and, optionally, an Atrial Fibrillation Drug. Arctic Front Cardiac Cryoablation System : The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation.
All Cause Mortality
	Treated With Cryoablation
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treated With Cryoablation
	Affected / at Risk (%)	# Events
Total	12/78 (15.4%)
Blood and lymphatic system disorders
INR ratio increased	1/78 (1.3%)	1
Cardiac disorders
Atrial Fibrillation	6/78 (7.7%)	8
Atrial Flutter	1/78 (1.3%)	1
Cardiac Tamponade	1/78 (1.3%)	1
Dizziness	1/78 (1.3%)	1
Gastrointestinal disorders
Bleeding Duodenal Ulcer	1/78 (1.3%)	1
Nervous system disorders
Cerebrovascular Accident	1/78 (1.3%)	1
Renal and urinary disorders
Acute Renal Failure	1/78 (1.3%)	1
Reproductive system and breast disorders
Orchitis	1/78 (1.3%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/78 (1.3%)	1
Surgical and medical procedures
Drug Therapy	1/78 (1.3%)	2
Bladder Repair	1/78 (1.3%)	1
Vascular disorders
Migraine	1/78 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Treated With Cryoablation
	Affected / at Risk (%)	# Events
Total	33/78 (42.3%)
Cardiac disorders
PALPITATIONS	8/78 (10.3%)	11
ATRIAL FLUTTER	7/78 (9%)	9
ATRIAL FIBRILLATION	7/78 (9%)	9
Gastrointestinal disorders
NAUSEA	7/78 (9%)	7
General disorders
CATHETER SITE HAEMATOMA	11/78 (14.1%)	16
CATHETER SITE HAEMORRHAGE	7/78 (9%)	9
Respiratory, thoracic and mediastinal disorders
COUGH	6/78 (7.7%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.