View Clinical Trial (Medical Research Study)
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation
| City: |
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Austin |
| State: |
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Texas |
| Zip Code: |
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78756 |
| Conditions: |
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Paroxysmal Atrial Fibrillation |
| Purpose: |
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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).
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00964392 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Austin, Texas 78756
United States
Polly Mock, RN
Phone: 512-421-3851
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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