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

Primary Purpose

Heart Diseases, Arrhythmia, 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 Heart Diseases focused on measuring Atrial Fibrillation, Paroxysmal Atrial Fibrillation

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:

  • 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
  • Cedars-Sinai Medical Center
  • 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
  • Park Nicollet Institute
  • Mayo Clinic
  • The Valley Hospital
  • Mount Sinai School of Medicine
  • Duke University Medical Center
  • Cleveland Clinic Foundation
  • Ohio State University
  • University of Oklahoma
  • University of Pennsylvania
  • Texas Cardiac Arrhythmia Research Foundation
  • Inova Fairfax Hospital
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

THERMOCOOL® SMARTTOUCH™ Catheter

Arm Description

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Rate of Acute Success
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).

Full Information

First Posted
June 27, 2011
Last Updated
January 20, 2015
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01385202
Brief Title
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Official Title
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Arrhythmia, Atrial Fibrillation
Keywords
Atrial Fibrillation, Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
172 (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
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
Description
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).
Time Frame
12-months
Title
Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.
Description
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.
Time Frame
7 days of the AF ablation procedure
Secondary Outcome Measure Information:
Title
Rate of Acute Success
Description
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
Time Frame
End of procedure

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David J Wilber, MD
Organizational Affiliation
Loyola University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francis E Marchlinski, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Douglas L Packer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hiroshi Nakagawa, MD, Ph.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hans Kottkamp, MD
Organizational Affiliation
University Leipzig
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
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
Park Nicollet Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
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
Mount 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 Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29759747
Citation
Reddy VY, Pollak S, Lindsay BD, McElderry HT, Natale A, Kantipudi C, Mansour M, Melby DP, Lakkireddy D, Levy T, Izraeli D, Sangli C, Wilber D. Relationship Between Catheter Stability and 12-Month Success After Pulmonary Vein Isolation: A Subanalysis of the SMART-AF Trial. JACC Clin Electrophysiol. 2016 Nov;2(6):691-699. doi: 10.1016/j.jacep.2016.07.014. Epub 2016 Nov 21.
Results Reference
derived
PubMed Identifier
25125294
Citation
Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
Results Reference
derived

Learn more about this trial

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

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