View Clinical Trial (Medical Research Study)
ABLATE AF Registry Trial (AtriCure Synergy Bipolar RF Energy Lesions for Non-paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery)
| City: |
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Indianapolis |
| State: |
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Indiana |
| Zip Code: |
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46290 |
| Conditions: |
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Atrial Fibrillation |
| Purpose: |
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ABLATE AF is a prospective, non-randomized multi-center clinical trial to demonstrate the
safety and effectiveness of the AtriCure Bipolar System for treating non-paroxysmal forms of
atrial fibrillation.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. Subject is greater than or equal to 18 years of age
2. Subject has history of a non-paroxysmal form of AF
3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for
one or more of the following:
- Mitral valve repair or replacement
- Aortic valve repair or replacement
- Tricuspid valve repair or replacement
- Coronary Artery Bypass procedures
4. Subject's Left Ventricular Ejection Fraction ≥ 30%
5. Subject is able and willing to provide written informed consent and comply with study
requirements
6. Subject has life expectancy of at least 1 year
Exclusion Criteria:
1. Stand alone AF without indication(s) for concomitant CABG, valve surgery
2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical
Maze procedure
3. Wolff-Parkinson-White syndrome
4. Prior cardiac surgery (Redo)
5. Class IV NYHA heart failure symptoms
6. Prior history of cerebrovascular accidents within 6 months or at any time if there is
residual neurological deficit
7. Documented MI within 6 weeks prior to study enrollment
8. Need for emergent cardiac surgery (i.e. cardiogenic shock)
9. Known carotid artery stenosis greater than 80%
10. LA size greater than or equal to 8cm
11. Current diagnosis of active systemic infection
12. Severe peripheral arterial occlusive disease defined as claudication with minimal
exertion
13. Pregnancy or desire to get pregnant within 12-months of the study enrollment
14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
15. Renal failure requiring dialysis or hepatic failure
16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
17. Therapy resulting in compromised tissue integrity including: thoracic radiation,
chemotherapy, long term treatment with oral or injected steroids, or known
connective tissue disorders
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| NCT ID: |
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NCT01174745 |
| Primary Contact: |
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Principal Investigator
Robert Hooker
Spectrum Health Hospitals
Rebecca Walters
Phone: 1-800-401-3506
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| Backup Contact: |
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N/A |
| Location Contact: |
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Indianapolis, Indiana 46290
United States
Cassie Sanders
Phone: 317-583-7804
Email: msanders@corvascmds.com
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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