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

• ClinicalTrials.gov Identifier: NCT00116428
• Recruitment Status: Completed
• First Posted: June 30, 2005
• Results First Posted: March 14, 2013
• Last Update Posted: October 24, 2017
• Sponsor: Biosense Webster, Inc.
• Information provided by (Responsible Party): Biosense Webster, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Heart Diseases; Arrhythmia; Atrial Fibrillation	Device: NAVISTAR® THERMOCOOL® Catheter; Drug: Antiarrhythmic drug	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
• Actual Study Start Date: October 1, 2004
• Actual Primary Completion Date: October 1, 2007
• Actual Study Completion Date: March 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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. ]
   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.
2. 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 ]
   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 :

1. The Percentage of Subjects Who Achieved Acute Success. [ Time Frame: 90 days post study procedure ]
   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.
2. Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up. [ Time Frame: During the two years of post procedure ]
   At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
3. Percentage of Subjects Responded to Each of the Four Health Status Categories. [ Time Frame: During the two years of post procedure ]
   At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Czechia

Na Homolce Hospital

Praha 5, Motol, Czechia, 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 of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT00116428 History of Changes
• Other Study ID Numbers: BWI03130
• First Posted: June 30, 2005
• Results First Posted: March 14, 2013
• Last Update Posted: October 24, 2017
• Last Verified: September 2017

Keywords provided by Biosense Webster, Inc.:

Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Additional relevant MeSH terms:

Atrial Fibrillation; Heart Diseases; Arrhythmias, Cardiac; Cardiovascular Diseases; Pathologic Processes; Anti-Arrhythmia Agents