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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385202
• Other study ID #: Smart-AF
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2011
• Last updated: January 20, 2015
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: January 2015
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• 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:

• 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation
• Heart Diseases

Intervention

Device:
• THERMOCOOL® SMARTTOUCH™ Catheter
AF Ablation

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research 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	Inova Fairfax Hospital	Fairfax	Virginia
United States	University of Kansas Hospitals	Kansas City	Kansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Loyola University Chicago	Maywood	Illinois
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Park Nicollet Institute	Minneapolis	Minnesota
United States	Mount 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 Pennsylvania	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

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	12-months	No
Primary	Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.	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.	7 days of the AF ablation procedure	Yes
Secondary	Rate of Acute Success	Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).	End of procedure	No