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NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation | Clinical Trials | Clareo Health

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

NCT00116428•Biosense Webster, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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.
•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.
+17 more criteria

Locations (17)

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

Key Dates

Start Date

October 1, 2004

Primary Completion Date

October 1, 2007

Completion Date

March 1, 2011

Last Updated

October 24, 2017

Enrollment

167

ACTUAL participants

Conditions

Heart DiseasesArrhythmiaAtrial Fibrillation

Interventions

NAVISTAR® THERMOCOOL® Catheter

DEVICE

Antiarrhythmic drug

DRUG

The CONFORM Pivotal Trial

NCT05147792

Atrial FibrillationStroke

View study

RECRUITINGNA

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

NCT06935591

Atrial Fibrillation (AF)

View study

RECRUITINGNA

The Fourth Left Atrial Appendage Occlusion Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The CONFORM Pivotal Trial

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

The Fourth Left Atrial Appendage Occlusion Study

Lumason® Infusion vs. Bolus Administrations

Medtronic Terminate AF Study

The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study