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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

August 20, 2009
April 4, 2014
September 2009
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00964392 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation

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).

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
  • 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 2
    Physicians who perform less than 50 atrial fibrillation ablation procedures per year.
    Interventions:
    • Procedure: Atrial Fibrillation ablation procedure
    • Device: NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL
  • Experimental: Arm 1
    Physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year.
    Interventions:
    • Procedure: Atrial Fibrillation ablation procedure
    • Device: NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
402
December 2018
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00964392
PMA #P030031/S014
Not Provided
Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
Not Provided
Biosense Webster, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP