THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

Phase 3

Completed

Conditions: Atrial Fibrillation
Heart Diseases
Arrhythmia

Interventions: Device: THERMOCOOL® SMARTTOUCH™ Catheter

Registration Number: NCT01385202

Lead Sponsor: Biosense Webster, Inc.

Brief Summary: The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 172

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

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
THERMOCOOL® SMARTTOUCH™ Catheter	THERMOCOOL® SMARTTOUCH™ Catheter	-

Primary Outcome Measures

Name	Time	Method
The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up	12-months	The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).
Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.	7 days of the AF ablation procedure	Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), 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
Rate of Acute Success	End of procedure	Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).

Trial Locations

Locations (23): Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States
Stanford University School of Medicine
🇺🇸
Stanford, California, United States
University of Kansas Hospitals
🇺🇸
Kansas City, Kansas, United States
Mount Sinai School of Medicine
🇺🇸
New York, New York, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸
Austin, Texas, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
University of Alabama, Birmingham
🇺🇸
Birmingham, Alabama, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Loyola University Chicago
🇺🇸
Maywood, Illinois, United States
Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Park Nicollet Institute
🇺🇸
Minneapolis, Minnesota, United States
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
The Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
University of Oklahoma
🇺🇸
Oklahoma City, Oklahoma, United States
Inova Fairfax Hospital
🇺🇸
Fairfax, Virginia, United States