Status:
COMPLETED
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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) physician...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2018
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT00964392
Start Date
September 1 2009
End Date
January 5 2018
Last Update
February 4 2025
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