AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation - NCT00560885-22042 (Clinical Trial 191568)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy191568.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Falls Church |
|
State:
|
|
VA |
| Zip Code: |
|
22042 |
| Conditions: |
|
Atrial Fibrillation |
| Purpose: |
|
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the
safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial
fibrillation during concomitant on-pump cardiac surgery.
|
| Study summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
1. Subject is greater than or equal to 18 years of age
2. Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESC
Guidelines
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
- Atrial Septal Defect Repair
- Patent Foramen Ovale closure
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, ASD repair,
or PFO closure
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 |
|
|
|
| Study is available at: |
|
Inova Fairfax
Falls Church, VA 22042
United States
Primary Contact:
Christine Pierre
Phone: 410-465-2455
Secondary Contact:
Alison Sathe
Phone: 1-800-401-3506 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|