Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2005-08-31
2009-10-31
Brief Summary
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This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at a single study site
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
RF ablation
RF catheter ablation
RF ablation using mesh device
Interventions
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RF catheter ablation
RF ablation using mesh device
Eligibility Criteria
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Inclusion Criteria
2. Patients with a minimum of 2 episodes of symptomatic PAF within the last 6 months prior to baseline evaluation. At least one of these episodes must have been documented. Documentation may include electrocardiogram (ECG), trans telephonic monitoring (TTM), Holter monitoring (HM), or telemetry strip. Additional PAF episodes (i.e., verbal accounts from the patient) will be documented in the patient's study record.
3. Patients who have failed at least 1 class I or class III anti-arrhythmic medication regimen.
4. Patients with the ability to understand the requirements of the study, who have provided written informed consent and agreed to the study restrictions and to return for the required follow-up assessments.
Exclusion Criteria
2. Permanent or persistent atrial fibrillation.
3. Recent myocardial infarction within 2 months
4. Currently unstable angina.
5. Any cardiac surgery during the previous 3 months.
6. Currently documented intracardiac thrombus by transesophageal echocardiography (TEE).
7. A left atrium \> 50mm in major dimension.
8. A common ostium larger than 25 mm in major axis or any individual pulmonary vein larger than 25 mm in major axis.
9. Permanent leads in or through the right atrium.
10. Clinically significant valvular heart disease or a replacement heart valve.
11. Congestive heart failure (NYHA classification III or IV).
12. An ejection fraction \<35%.
13. A contraindication to warfarin.
14. A contraindication to transseptal procedure.
15. Any cerebral ischemic event, including any transient ischemic attack (TIA), in the preceding 6 months.
16. Any known bleeding disorder.
17. Women who are known to be pregnant or nursing.
18. Uncontrolled hyperthyroidism.
19. Patients currently enrolled in any other clinical investigation.
20. Any other significant uncontrolled or unstable medical condition.
21. A life expectancy of less than one year.
22. Currently taking amiodarone or have taken amiodarone within 4 months prior to baseline evaluation.
18 Years
85 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Locations
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David Haines, MD
Royal Oak, Michigan, United States
Countries
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Other Identifiers
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BEP-4405
Identifier Type: -
Identifier Source: org_study_id
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