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

NCT ID: NCT00116428

Last Updated: 2017-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-01
• Study Completion Date: 2011-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NAVISTAR® THERMOCOOL® Catheter

Group Type: EXPERIMENTAL

NAVISTAR® THERMOCOOL® Catheter

Intervention Type: 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.

Antiarrhythmic drug

Group Type: ACTIVE_COMPARATOR

Antiarrhythmic drug

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wilber, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Marin General Hospital

Greenbrae, California, United States

Florida Hospital

Orlando, Florida, United States

Loyola University Medical Center

Maywood, Illinois, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

St. Lukes Roosevelt Hospital

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

The Heart Hospital Baylor Plano Baylor Research Institute

Plano, Texas, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Hospital Sao Paulo

São Paulo, , Brazil

Montreal Heart Institute

Montreal, Quebec, Canada

Na Homolce Hospital

Prague, Motol, Czechia

Hospital San Raffaele

Milan, , Italy

Countries

United States; Brazil; Canada; Czechia; Italy

References

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.

Reference Type: RESULT

PMID: 20103757 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20940250 (View on PubMed)

Other Identifiers

BWI03130

Identifier Type: -

Identifier Source: org_study_id