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

Phase 3

Completed

Interventions: Device: NAVISTAR® THERMOCOOL® Catheter
Drug: Antiarrhythmic drug

Brief 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 & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
NAVISTAR® THERMOCOOL® Catheter	NAVISTAR® THERMOCOOL® Catheter	-
Antiarrhythmic drug	Antiarrhythmic drug	-

Primary Outcome Measures

Name	Time	Method
The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)	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.	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 Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious 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

Name	Time	Method
The Percentage of Subjects Who Achieved Acute Success.	90 days post study procedure	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.
Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.	During the two years of post procedure	At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Percentage of Subjects Responded to Each of the Four Health Status Categories.	During the two years of post procedure	At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.

Locations (17): University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
Marin General Hospital
🇺🇸
Greenbrae, California, United States
St. Lukes Roosevelt Hospital
🇺🇸
New York, New York, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
The Heart Hospital Baylor Plano Baylor Research Institute
🇺🇸
Plano, Texas, United States
Hospital Sao Paulo
🇧🇷
Sao Paulo, Brazil
Montreal Heart Institute
🇨🇦
Montreal, Quebec, Canada
Hospital San Raffaele
🇮🇹
Milan, Italy
Na Homolce Hospital
🇨🇿
Praha 5, Motol, Czechia
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Lahey Clinic Medical Center
🇺🇸
Burlington, Massachusetts, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States