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

NCT01639495 | Completed Phase 3 Results FDA Device

• 1 other identifier: SMART-AF CA
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 20

Brief Summary

This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

Conditions

Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Keywords

Drug refractory; Atrial fibrillation; Antiarrhythmic drug failure; Atrial tachyarrhythmias

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Peri-procedural Serious Adverse Events

  Within 8-30 days post procedure

• Percentage of Subjects Achieved Acute Effectiveness

  5 hours of procedure time

• Late Onset Serious Adverse Events

  From 31 days post procedure to month 12

Study Arms (1)

THERMOCOOL® SMARTTOUCH™ Catheter

EXPERIMENTAL

Device: THERMOCOOL® SMARTTOUCH™ Catheter

Interventions

THERMOCOOL® SMARTTOUCH™ Catheter DEVICE

AF Ablation

THERMOCOOL® SMARTTOUCH™ Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (20)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

University of Kansas Hospitals

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennslyvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Cardiac Arrhythmia Foundation

Austin, Texas, 78705, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert Stagg, PhD, Manager, Clinical Franchise
• Organization: Biosense Webster, Inc.

rstagg@its.jnj.com

(949) 450-7779

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study had a single arm: catheter ablation for PAF

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 12, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 15, 2018
• Results First Posted: May 15, 2018

Record last verified: 2018-04

Locations

US (20)