Status:
COMPLETED
Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
Lead Sponsor:
AtriCure, Inc.
Conditions:
Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
- Patient is willing and able to provide written informed consent.
- Patient has a life expectancy of at least 2 years.
- Patient is willing and able to attend the scheduled follow-up visits.
Exclusion
- Prior Cardiothoracic Surgery.
- Patient has NYHA Class IV heart failure.
- Evidence of underlying structural heart disease requiring surgical treatment.
- Ejection fraction \< 30%
- Measured left atrial diameter \> 6.0 cm
- Renal Failure
- Stroke within previous 6 months.
- Known carotid artery stenosis greater than 80%.
- Evidence of significant active infection or endocarditis.
- Pregnant woman or women desiring to become pregnant in the next 24 months.
- Presence of thrombus in the left atrium determined by echocardiography.
- History of blood dyscrasia.
- Contraindication to anticoagulation, based on Investigator's opinion.
- Mural thrombus or tumor.
- Moderate to Severe COPD
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01246466
Start Date
December 1 2010
End Date
November 1 2013
Last Update
April 1 2021
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University Medical Center
Stanford, California, United States, 94305
2
Vanderbilt Heart Institute
Nashville, Tennessee, United States, 37232
3
Baylor Health
Plano, Texas, United States, 75093
4
UVA
Charlottesville, Virginia, United States, 22908