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

This study is currently recruiting participants.
Verified March 2012 by Biosense Webster, Inc.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00964392
First received: August 20, 2009
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 381
Study Start Date: September 2009
Estimated Primary Completion Date: September 2016 (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:

  • Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment 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 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:

  • 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 (e.g. TEE).
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964392

  Show 22 Study Locations
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: March 21, 2012
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 June 13, 2013