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

NCT00116428 | Completed Phase 3 Results DMC

• 1 other identifier: BWI03130
• Study Type: interventional
• Target: 167
• Locations: 5 countries
• Sites: 17

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.

Conditions

Heart Diseases; Arrhythmia; Atrial Fibrillation

Keywords

Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The Percentage of Subjects Who Achieved Acute Success.

  90 days post study procedure

• Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.

  During the two years of post procedure

• Percentage of Subjects Responded to Each of the Four Health Status Categories.

  During the two years of post procedure

Study Arms (2)

NAVISTAR® THERMOCOOL® Catheter

EXPERIMENTAL

Device: NAVISTAR® THERMOCOOL® Catheter

Antiarrhythmic drug

ACTIVE COMPARATOR

Drug: Antiarrhythmic drug

Interventions

NAVISTAR® THERMOCOOL® Catheter DEVICE

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.

NAVISTAR® THERMOCOOL® Catheter

Antiarrhythmic drug 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.

Antiarrhythmic drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (17)

Marin General Hospital

Greenbrae, California, 94904, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Lahey Clinic Medical Center

Burlington, Massachusetts, 01805, United States

Location

St. Lukes Roosevelt Hospital

New York, New York, 10025, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43241, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

The Heart Hospital Baylor Plano Baylor Research Institute

Plano, Texas, 75093, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Hospital Sao Paulo

São Paulo, 04024-002, Brazil

Location

Montreal Heart Institute

Montreal, Quebec, H1T-iC8, Canada

Location

Na Homolce Hospital

Prague, Motol, 150 30, Czechia

Location

Hospital San Raffaele

Milan, 20132, Italy

Location

Related Publications (2)

• 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.

  PMID: 20103757 RESULT

• 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.

  PMID: 20940250 DERIVED

MeSH Terms

Conditions

Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Melissa Schultz, Project Manager, Regulatory Affairs
• Organization: Biosense Webster

mschult1@its.jnj.com

800-729-9010

Study Officials

• David Wilber, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2005
• First Posted: June 30, 2005
• Study Start: October 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2011
• Last Updated: October 24, 2017
• Results First Posted: March 14, 2013

Record last verified: 2017-09

Locations

CA (1); IT (1); US (13); CZ (1); BR (1)