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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00116428
First received: June 29, 2005
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Heart Diseases
Arrhythmia
Atrial Fibrillation
Device: NAVISTAR® THERMOCOOL® Catheter
Drug: Antiarrhythmic drug
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) [ 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 7 Days of Ablation Procedure ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 90 days post study procedure ] [ Designated as safety issue: No ]
    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. [ Time Frame: During the two years of post procedure ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: During the two years of post procedure ] [ Designated as safety issue: Yes ]
    At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.


Enrollment: 167
Study Start Date: October 2004
Study Completion Date: March 2011
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NAVISTAR® THERMOCOOL® Catheter Device: NAVISTAR® THERMOCOOL® Catheter
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.
Active Comparator: Antiarrhythmic drug Drug: Antiarrhythmic drug
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116428

Locations
United States, California
Marin General Hospital
Greenbrae, California, United States, 94904
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
United States, New York
St. Lukes Roosevelt Hospital
New York, New York, United States, 10025
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43241
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Texas
The Heart Hospital Baylor Plano Baylor Research Institute
Plano, Texas, United States, 75093
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Brazil
Hospital Sao Paulo
Sao Paulo, Brazil, 04024-002
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T-iC8
Czech Republic
Na Homolce Hospital
Praha 5, Motol, Czech Republic, 150 30
Italy
Hospital San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: David Wilber, MD Loyola University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00116428     History of Changes
Other Study ID Numbers: BWI03130
Study First Received: June 29, 2005
Results First Received: February 11, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation

Additional relevant MeSH terms:
Heart Diseases
Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014