NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation (AF Registry)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00964392
First received: August 20, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Procedure: Atrial Fibrillation ablation procedure
Device: NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • The primary safety endpoint is the percentage of subjects in each registry arm experiencing primary adverse events within seven (7) days of the ablation procedure. [ Time Frame: 1 month, yearly for 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A. Long-term (5 year) occurrence of Serious Adverse Events. B. Long-term (5 year) symptomatic AF recurrence. [ Time Frame: Yearly for 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 402
Study Start Date: September 2009
Estimated Study Completion Date: December 2018
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 2
Physicians who perform less than 50 atrial fibrillation ablation procedures per year.
Procedure: Atrial Fibrillation ablation procedure
Radiofrequency ablation procedure
Device: NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL
The NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters are diagnostic/ablation deflectable tip, luminal catheters designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency.
Experimental: Arm 1
Physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year.
Procedure: Atrial Fibrillation ablation procedure
Radiofrequency ablation procedure
Device: NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL
The NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters are diagnostic/ablation deflectable tip, luminal catheters designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency.

Detailed Description:

This registry is a prospective, multi-center, non-randomized post approval evaluation comprised of two (2) registry arms with independent hypotheses. The registry arms are defined as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be considered for this post approval registry. This registry will be conducted at up to 40 centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for commercial distribution under PMA #P030031/S11.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Candidates for this registry must meet ALL of the following criteria:

  • Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment and one AF episode documented within the one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
  • Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF, or intolerable side effects.
  • Age 18 years or older.
  • Able and willing to comply with all pre-, post- and follow-up testing and requirements.
  • Signed Patient Informed Consent Form.

Exclusion Criteria:

Candidates will be excluded from the registry if any of the following conditions apply:

  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  • AF episodes that last longer than 30 days and are terminated via cardioversion.
  • CABG procedure within the last six (6) months.
  • Awaiting cardiac transplantation or other cardiac surgery.
  • Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA).
  • History of a documented thromboembolic event within the past one (1) year.
  • Diagnosed atrial myxoma.
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this registry.
  • 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.
  • Uncontrolled heart failure.
  • Myocardial infarction within the previous two (2) months.
  • History of blood clotting or bleeding abnormalities.
  • Contraindication to anticoagulation (i.e. heparin or warfarin).
  • Life expectancy less than 12 months.
  • Enrollment in an investigational study evaluating another device or drug.
  • Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964392

  Hide Study Locations
Locations
United States, Florida
Diagnostic Cardiology Associates PA
Jacksonville, Florida, United States, 32204
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
University of Maryland
Baltimore, Maryland, United States, 21201
Washington Adventist Hospital
Silver Spring, Maryland, United States, 20903
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Park Nicollet Institute
Minneapolis, Minnesota, United States, 55416
United States, New York
St. Luke's Roosevelt Hospital
New York, New York, United States, 10025
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Austin Heart PA
Austin, Texas, United States, 78756
United States, Virginia
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22031
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, Quebec
Montreal Heart Institute (Institut de Cardiologie de Montreal)
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Biosense Webster, Inc.
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00964392     History of Changes
Other Study ID Numbers: PMA #P030031/S014
Study First Received: August 20, 2009
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014