NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study

Last updated: January 31, 2025
Sponsor: Biosense Webster, Inc.
Overall Status: Terminated

Phase

3

Condition

Cardiac Disease

Atrial Fibrillation

Arrhythmia

Treatment

Radiofrequency Ablation

Clinical Study ID

NCT00721149
BWI03130TXA
  • Ages > 18
  • All Genders

Study Summary

This trial evaluates the safety and effectiveness of catheter ablation for PAF. 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 sustained ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with symptomatic PAF who have had three (3) AF episodes in the six (6)months prior to enrollment, one of which must be documented. Documentation mayinclude 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 suchas beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrentsymptomatic 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 andrequirements.

Exclusion

Exclusion Criteria:

  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, orreversible 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 orchronic obstructive pulmonary disease) or any other disease or malfunction of thelungs or respiratory system that produces chronic symptoms.

  • Significant congenital anomaly or medical problem that in the opinion of theinvestigator would preclude enrollment in this study.

  • Women who are pregnant (by history of menstrual period or pregnancy test if thehistory 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 catheterintroduction or manipulation.

  • Presence of a condition that precludes vascular access.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Radiofrequency Ablation
Phase: 3
Study Start date:
September 01, 2008
Estimated Completion Date:
December 31, 2009

Connect with a study center

  • Montreal Heart Institute

    Montreal, Quebec H1T 1CB
    Canada

    Site Not Available

  • University of Alabama, Birmingham Medical Center

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Arizona Arrhythmia Consultants

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Marin General Hospital

    Greenbrae, California 94904
    United States

    Site Not Available

  • Florida Hospital Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Loyola University Medical Center Chicago

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • St. Luke's Roosevelt Hospital

    New York, New York 10025
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • The Pennsylvania State University and Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Texas Cardiac Associates

    Rowlett, Texas 75088
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.