Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
| Verified date | April 2018 |
| Source | Biosense Webster, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
| Status | Completed |
| Enrollment | 148 |
| Est. completion date | October 1, 2014 |
| Est. primary completion date | June 1, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Have had at least 3 atrial fibrillation episodes within 6 months of this study - Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes - 18 years of age or older Exclusion Criteria including, but not limited to: - Have had previous ablation for atrial fibrillation - Have take amiodarone within 6 months of this study - Have had any heart surgery within the last 60 days - Have had a heart attack within the last 60 days - Females who are pregnant or breast feeding |
| Country | Name | City | State |
|---|---|---|---|
| United States | Piedmont Heart Institute | Atlanta | Georgia |
| United States | Texas Cardiac Arrhythmia Foundation | Austin | Texas |
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | University of Alabama, Birmingham | Birmingham | Alabama |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Ohio State University | Columbus | Ohio |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | University of Kansas Hospitals | Kansas City | Kansas |
| United States | Loyola University Chicago | Maywood | Illinois |
| United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
| United States | Mt. Sinai School of Medicine | New York | New York |
| United States | University of Oklahoma | Oklahoma City | Oklahoma |
| United States | Florida Hospital | Orlando | Florida |
| United States | University of Pennslyvania | Philadelphia | Pennsylvania |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | The Valley Hospital | Ridgewood | New Jersey |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Stanford University School of Medicine | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Biosense Webster, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias | Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures | Day 91-361 | |
| Primary | Incidence of Primary Adverse Events Within Specified Study Period | Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary 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, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block. | 12 months post procedure | |
| Secondary | Peri-procedural Serious Adverse Events | Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure | Within 8-30 days post procedure | |
| Secondary | Percentage of Subjects Achieved Acute Effectiveness | Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins | 5 hours of procedure time | |
| Secondary | Late Onset Serious Adverse Events | Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure | From 31 days post procedure to month 12 |