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

Primary Purpose

Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
THERMOCOOL® SMARTTOUCH™ Catheter
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation focused on measuring Drug refractory, Atrial fibrillation, Antiarrhythmic drug failure, Atrial tachyarrhythmias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama, Birmingham
  • Stanford University School of Medicine
  • Florida Hospital
  • Piedmont Heart Institute
  • Loyola University Chicago
  • University of Kansas Hospitals
  • Johns Hopkins Hospital
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Abbott Northwestern Hospital
  • Mayo Clinic
  • The Valley Hospital
  • Mt. Sinai School of Medicine
  • Duke University Medical Center
  • Cleveland Clinic Foundation
  • Ohio State University
  • University of Oklahoma
  • University of Pennslyvania
  • Texas Cardiac Arrhythmia Foundation
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

THERMOCOOL® SMARTTOUCH™ Catheter

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Peri-procedural Serious Adverse Events
Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure
Percentage of Subjects Achieved Acute Effectiveness
Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins
Late Onset Serious Adverse Events
Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure

Full Information

First Posted
July 10, 2012
Last Updated
April 16, 2018
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01639495
Brief Title
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
Official Title
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2012 (Actual)
Primary Completion Date
June 1, 2014 (Actual)
Study Completion Date
October 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
Detailed Description
The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Keywords
Drug refractory, Atrial fibrillation, Antiarrhythmic drug failure, Atrial tachyarrhythmias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
This study had a single arm: catheter ablation for PAF
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THERMOCOOL® SMARTTOUCH™ Catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
THERMOCOOL® SMARTTOUCH™ Catheter
Intervention Description
AF Ablation
Primary Outcome Measure Information:
Title
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias
Description
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
Time Frame
Day 91-361
Title
Incidence of Primary Adverse Events Within Specified Study Period
Description
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.
Time Frame
12 months post procedure
Secondary Outcome Measure Information:
Title
Peri-procedural Serious Adverse Events
Description
Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure
Time Frame
Within 8-30 days post procedure
Title
Percentage of Subjects Achieved Acute Effectiveness
Description
Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins
Time Frame
5 hours of procedure time
Title
Late Onset Serious Adverse Events
Description
Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure
Time Frame
From 31 days post procedure to month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Hospitals
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Mt. Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennslyvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Cardiac Arrhythmia Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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