AFTX: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00721149
• Collaborator: (none)
• Enrollment: 10
• Locations: 4
• Arm: 1
• Duration (Months): 15
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic sustained ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases; Arrhythmia; Atrial Fibrillation	Device: Radiofrequency Ablation	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NaviStar ThermoCool	Device: Radiofrequency Ablation; The Biosense Webster® NAVISTAR THERMOCOOL Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361. [From study day 91 through day 361]

   A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).

2. The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events. [within 7 days of ablation procedure]

   Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.

Secondary Outcome Measures

1. Percentage of Subjects Who Achieved Acute Success [Day 91 - 361]

   Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.

2. 24-hour Holter Data [1 year]

3. TTM Data [1 year]

4. Percentage of Subjects Who Responded to Quality of Life Assessment [1 year]

   SF 36 Symptom Frequency and Severity Checklist

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.

• Failure of at least one AAD for PAF [class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD.

• Signed Patient Informed Consent Form.

• Age 18 years or older.

• Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria:

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non- cardiac cause.

• Previous ablation for atrial fibrillation.

• Patients on amiodarone therapy at any time during the previous six (6) months.

• AF episodes that last longer than 30 days and are terminated via cardioversion.

• Any valvular cardiac surgical procedure.

• CABG procedure within the last 180 days (six months).

• Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).

• Documented left atrial thrombus on imaging (e.g. TEE).

• History of a documented thromboembolic event within the past one (1) year.

• Diagnosed atrial myxoma.

• Presence of implanted ICD.

• Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.

• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.

• Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).

• Acute illness or active systemic infection or sepsis.

• Unstable angina.

• Myocardial infarction within the previous 60 days (two months).

• LVEF < 40%.

• History of blood clotting or bleeding abnormalities.

• Contraindication to anticoagulation (i.e. heparin or warfarin).

• Contraindication to CT/MRA procedure.

• Life expectancy less than 360 days (12 months).

• Enrollment in an investigational study evaluating another device or drug.

• Uncontrolled heart failure or NYHA class III or IV heart failure.

• Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.

• Presence of a condition that precludes vascular access.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642
2	Duke University Medical Center	Durham	North Carolina	United States	27710
3	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
4	Ohio State University Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

• Principal Investigator: David Wilber, MD, Loyola University Medical Center Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT00721149
• Other Study ID Numbers: BWI03130TXA
• First Posted: Jul 23, 2008
• Last Update Posted: Jan 22, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Biosense Webster, Inc.: Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Ablation; Non-randomized
• Additional relevant MeSH terms: Atrial Fibrillation; Heart Diseases

Study Results

Participant Flow

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter
Arm/Group Description	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Period Title: Overall Study
STARTED	10
COMPLETED	9
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter
Arm/Group Description	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.2 (13.2)
Sex: Female, Male (Count of Participants)
Female	5 50%
Male	5 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	10 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%
Hypertension Condition (Number) [Number]
With Hypertension	3 30%
Without Hypertension	7 70%
Atrial Flutter Condition (Number) [Number]
With Atrial Flutter	2 20%
Without Atrial Flutter	8 80%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.
Description	A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).
Time Frame	From study day 91 through day 361

Outcome Measure Data

Analysis Population Description

The subjects who had a study ablation procedure.

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter
Arm/Group Description	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Measure Participants	9
Number [Percentage of participants]	66.7 667%

2. Primary Outcome

Title	The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.
Description	Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.
Time Frame	within 7 days of ablation procedure

Outcome Measure Data

Analysis Population Description

The subjects who had a study ablation procedure.

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter
Arm/Group Description	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Measure Participants	9
Number [Percentage of participants]	0.0 0%

3. Secondary Outcome

Title	Percentage of Subjects Who Achieved Acute Success
Description	Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.
Time Frame	Day 91 - 361

Outcome Measure Data

Analysis Population Description

The subjects who had a study ablation procedure.

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter
Arm/Group Description	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Measure Participants	9
Number [Percentage of participants]	100 1000%

4. Secondary Outcome

Title	24-hour Holter Data
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter
Arm/Group Description	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Measure Participants	0

5. Secondary Outcome

Title	TTM Data
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter
Arm/Group Description	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Measure Participants	0

6. Secondary Outcome

Title	Percentage of Subjects Who Responded to Quality of Life Assessment
Description	SF 36 Symptom Frequency and Severity Checklist
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter
Arm/Group Description	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Measure Participants	0

Adverse Events

Arm/Group Title	NAVISTAR® THERMOCOOL® Catheter
Arm/Group Description	The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
All Cause Mortality
	NAVISTAR® THERMOCOOL® Catheter
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	NAVISTAR® THERMOCOOL® Catheter
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	NAVISTAR® THERMOCOOL® Catheter
	Affected / at Risk (%)	# Events
Total	2/9 (22.2%)
Blood and lymphatic system disorders
Small hematoma - left groin	1/9 (11.1%)	1
Hepatobiliary disorders
Gallstone, pancreatitis, cholelithiasis	1/9 (11.1%)	1

Limitations/Caveats

Because of early study termination, the study did not reach its targeted enrollment and study data analysis was not fully conducted, thus study results may not be interpretable.

More Information

Certain Agreements

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

The PI is allowed to publish but must submit draft publication(s) to Biosense Webster, Inc. at least 30 days prior to submission for publication or presentation.