Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2010 |
| End Date: | November 2013 |
Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac
surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in
treating AF, and how effective this combined procedure is using the AtriCure System in
treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac
surgery and a standard electrophysiology catheter, currently available, will be used to
perform the catheter ablation procedure. This surgical procedure is considered less invasive
because it is done through tiny surgical punctures on the sides of the chest near the ribs
instead of one large surgical incision of the breast bone to completely open the chest and
access the heart, and it also avoids the need for the heart-lung bypass machine.
surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in
treating AF, and how effective this combined procedure is using the AtriCure System in
treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac
surgery and a standard electrophysiology catheter, currently available, will be used to
perform the catheter ablation procedure. This surgical procedure is considered less invasive
because it is done through tiny surgical punctures on the sides of the chest near the ribs
instead of one large surgical incision of the breast bone to completely open the chest and
access the heart, and it also avoids the need for the heart-lung bypass machine.
Inclusion Criteria:
1. Age > 18 years
2. Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue)
persistent or longstanding persistent AF Persistent
3. Patient is willing and able to provide written informed consent.
4. Patient has a life expectancy of at least 2 years.
5. Patient is willing and able to attend the scheduled follow-up visits.
Exclusion Criteria:
1. Prior Cardiothoracic Surgery.
2. Patient has NYHA Class IV heart failure.
3. Evidence of underlying structural heart disease requiring surgical treatment.
4. Ejection fraction < 30%
5. Measured left atrial diameter > 6.0 cm
6. Renal Failure
7. Stroke within previous 6 months.
8. Known carotid artery stenosis greater than 80%.
9. Evidence of significant active infection or endocarditis.
10. Pregnant woman or women desiring to become pregnant in the next 24 months.
11. Presence of thrombus in the left atrium determined by echocardiography.
12. History of blood dyscrasia.
13. Contraindication to anticoagulation, based on Investigator's opinion.
14. Mural thrombus or tumor.
15. Moderate to Severe COPD
We found this trial at
5
sites
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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