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

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 2
  • Physicians who perform less than 50 atrial fibrillation ablation procedures per year.
• Experimental: Arm 1
  • Physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year.

Primary 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
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Biosense Webster, Inc. Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00964392

Study ID Number: PMA #P030031/S014

ClinicalTrials.gov Identifier: NCT00964392

Health Authority: United States: Institutional Review Board