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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Atrial Fibrillation; Arrhythmia
• Intervention / Treatment: Device: NAVISTAR® THERMOCOOL® Catheter; Drug: Antiarrhythmic drug

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.
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.	Within 7 Days of Ablation Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days post study procedure
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.	During the two years of post procedure
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.	During the two years of post procedure

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: David Wilber, MD, Loyola University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2004
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: June 29, 2005
• First Submitted That Met QC Criteria: June 29, 2005
• First Posted (Estimate): June 30, 2005

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Paroxysmal Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Atrial Fibrillation; Anti-Arrhythmia Agents
• Other Study ID Numbers: BWI03130