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NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation (Afib IDE)

Primary Purpose

Heart Diseases, Arrhythmia, Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NAVISTAR® THERMOCOOL® Catheter
Antiarrhythmic drug
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

You may be eligible to participate in this study if you: Have failed to respond to drug treatment for your AFib, or find the side effects of your medication intolerable. Inclusion Criteria Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to randomization, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip. Failure of at least one AAD for PAF [class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD. Signed Patient Informed Consent Form. Age 18 years or older. Able and willing to comply with all pre-, post- and follow-up testing and requirements. Exclusion Criteria Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. Previous ablation for atrial fibrillation. Patients on amiodarone therapy at any time during the previous six (6) months. AF episodes that last longer than 30 days and are terminated via cardioversion. Any valvular cardiac surgical procedure. CABG procedure within the last 180 days (six months). Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months). Documented left atrial thrombus on imaging (e.g. TEE). History of a documented thromboembolic event within the past one (1) year. Diagnosed atrial myxoma. Presence of implanted ICD. Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable). Acute illness or active systemic infection or sepsis. Unstable angina. Myocardial infarction within the previous 60 days (two months). LVEF < 40%. History of blood clotting or bleeding abnormalities. Contraindication to anticoagulation (i.e. heparin or warfarin). Contraindication to CT/MRA procedure. Life expectancy less than 360 days (12 months). Enrollment in an investigational study evaluating another device or drug. Uncontrolled heart failure or NYHA class III or IV heart failure. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation. Presence of a condition that precludes vascular access. Left atrial size ≥ 50 mm

Sites / Locations

  • Marin General Hospital
  • Florida Hospital
  • Loyola University Medical Center
  • Johns Hopkins Hospital
  • Lahey Clinic Medical Center
  • St. Lukes Roosevelt Hospital
  • University of Rochester Medical Center
  • Ohio State University Medical Center
  • Riverside Methodist Hospital
  • University of Pennsylvania
  • Medical University of South Carolina
  • The Heart Hospital Baylor Plano Baylor Research Institute
  • Inova Fairfax Hospital
  • Hospital Sao Paulo
  • Montreal Heart Institute
  • Na Homolce Hospital
  • Hospital San Raffaele

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NAVISTAR® THERMOCOOL® Catheter

Antiarrhythmic drug

Arm Description

Outcomes

Primary Outcome Measures

The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.
The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events
Catheter-related 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,hospitalization (initial and prolonged), and heart block.

Secondary Outcome Measures

The Percentage of Subjects Who Achieved Acute Success.
Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.
Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.
At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Percentage of Subjects Responded to Each of the Four Health Status Categories.
At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.

Full Information

First Posted
June 29, 2005
Last Updated
September 22, 2017
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00116428
Brief Title
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
Acronym
Afib IDE
Official Title
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2004 (Actual)
Primary Completion Date
October 1, 2007 (Actual)
Study Completion Date
March 1, 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAVISTAR® THERMOCOOL® Catheter
Arm Type
Experimental
Arm Title
Antiarrhythmic drug
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
NAVISTAR® THERMOCOOL® Catheter
Intervention Description
The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drug
Intervention Description
Subjects randomized to the antiarrhythmic drug (control) arm will be prescribed to a not previously administered class I or class III antiarrhythmic drug that is currently approved in the U.S. for treating atrial fibrillation.
Primary Outcome Measure Information:
Title
The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Description
Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.
Time Frame
The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.
Title
The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events
Description
Catheter-related 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,hospitalization (initial and prolonged), and heart block.
Time Frame
Within 7 Days of Ablation Procedure
Secondary Outcome Measure Information:
Title
The Percentage of Subjects Who Achieved Acute Success.
Description
Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.
Time Frame
90 days post study procedure
Title
Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.
Description
At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Time Frame
During the two years of post procedure
Title
Percentage of Subjects Responded to Each of the Four Health Status Categories.
Description
At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Time Frame
During the two years of post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
You may be eligible to participate in this study if you: Have failed to respond to drug treatment for your AFib, or find the side effects of your medication intolerable. Inclusion Criteria Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to randomization, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip. Failure of at least one AAD for PAF [class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD. Signed Patient Informed Consent Form. Age 18 years or older. Able and willing to comply with all pre-, post- and follow-up testing and requirements. Exclusion Criteria Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. Previous ablation for atrial fibrillation. Patients on amiodarone therapy at any time during the previous six (6) months. AF episodes that last longer than 30 days and are terminated via cardioversion. Any valvular cardiac surgical procedure. CABG procedure within the last 180 days (six months). Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months). Documented left atrial thrombus on imaging (e.g. TEE). History of a documented thromboembolic event within the past one (1) year. Diagnosed atrial myxoma. Presence of implanted ICD. Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable). Acute illness or active systemic infection or sepsis. Unstable angina. Myocardial infarction within the previous 60 days (two months). LVEF < 40%. History of blood clotting or bleeding abnormalities. Contraindication to anticoagulation (i.e. heparin or warfarin). Contraindication to CT/MRA procedure. Life expectancy less than 360 days (12 months). Enrollment in an investigational study evaluating another device or drug. Uncontrolled heart failure or NYHA class III or IV heart failure. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation. Presence of a condition that precludes vascular access. Left atrial size ≥ 50 mm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Wilber, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marin General Hospital
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
St. Lukes Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43241
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
The Heart Hospital Baylor Plano Baylor Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Hospital Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T-iC8
Country
Canada
Facility Name
Na Homolce Hospital
City
Praha 5
State/Province
Motol
ZIP/Postal Code
150 30
Country
Czechia
Facility Name
Hospital San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20103757
Citation
Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):333-40. doi: 10.1001/jama.2009.2029.
Results Reference
result
PubMed Identifier
20940250
Citation
Reynolds MR, Walczak J, White SA, Cohen DJ, Wilber DJ. Improvements in symptoms and quality of life in patients with paroxysmal atrial fibrillation treated with radiofrequency catheter ablation versus antiarrhythmic drugs. Circ Cardiovasc Qual Outcomes. 2010 Nov;3(6):615-23. doi: 10.1161/CIRCOUTCOMES.110.957563. Epub 2010 Oct 12.
Results Reference
derived

Learn more about this trial

NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

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