NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— Afib IDE  

Official title:

NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116428
• Other study ID #: BWI03130
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2005
• Last updated: September 22, 2017
• Start date: October 1, 2004
• Est. completion date: March 1, 2011

Study information

• Verified date: September 2017
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. 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 ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 1, 2011
• Est. primary completion date: October 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

You may be eligible to participate in this study if you: Have failed to respond to drug treatment for your AFib, or find the side effects of your medication intolerable.

Inclusion Criteria

• Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to randomization, 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.

• Left atrial size = 50 mm

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation
• Heart Diseases

Intervention

Device:
• NAVISTAR® THERMOCOOL® Catheter
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.

Drug:
• Antiarrhythmic drug
Subjects randomized to the antiarrhythmic drug (control) arm will be prescribed to a not previously administered class I or class III antiarrhythmic drug that is currently approved in the U.S. for treating atrial fibrillation.

Locations

Country	Name	City	State
Brazil	Hospital Sao Paulo	Sao Paulo
Canada	Montreal Heart Institute	Montreal	Quebec
Czechia	Na Homolce Hospital	Praha 5	Motol
Italy	Hospital San Raffaele	Milan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Marin General Hospital	Greenbrae	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	St. Lukes Roosevelt Hospital	New York	New York
United States	Florida Hospital	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano Baylor Research Institute	Plano	Texas
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Czechia,  Italy, 

References & Publications (1)

Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)	Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.	The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.
Primary	The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events	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.	Within 7 Days of Ablation Procedure
Secondary	The Percentage of Subjects Who Achieved Acute Success.	Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.	90 days post study procedure
Secondary	Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.	At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.	During the two years of post procedure
Secondary	Percentage of Subjects Responded to Each of the Four Health Status Categories.	At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.	During the two years of post procedure