Clinical trial NCT00964392: NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
Official title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-24
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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 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.

Primary outcomes:
measure: The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.
timeFrame: Seven days post ablation procedure
Secondary outcomes:
measure: Percentage of Subjects Experienced Serious Adverse Events.
timeFrame: First study day to 5 year post-ablation
Other outcomes:
Locations:
Study officials:
References: