Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation
Brief summary
This is an early feasibility trial designed to demonstrate whether a new ablation device can be used safely and effectively in treating atrial fibrillation. This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at a single study site
Detailed description
This study is intended to evaluate the safety and preliminary effectiveness of the RFMesh BAS for electrophysiological mapping and radiofrequency ablation in the region of the ostium of a targeted pulmonary vein in the treatment of drug refractory paroxysmal atrial fibrillation.
Interventions
DEVICERF catheter ablation
RF ablation using mesh device
Sponsors
C. R. Bard
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are between 18 & 85 years of age. 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
1. Any previous ablation of the left atrium (surgical or catheter based). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the safety of the HDMA when used to map & ablate patients with AF, by assessing MCs at 7-days & 30 days post-procedure & assessing the occurrence of pulmonary vein stenosis at 3 & 12 months post-procedure. | 12 months |
| Evaluate the preliminary effectiveness of the HDMA when used to map and ablate patients with paroxysmal AF, by assessing APS & the freedom from recurrence of symptomatic AF at 3, 6 & 12 months post- procedure. | 12 months |
Countries
United States
Outcome results
None listed