Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
Completed · Not applicable
Conditions studied: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT01246466
- Run by
- AtriCure, Inc.
- People needed
- 24
- Starts
- 2010-12-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2021-04-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Stanford University Medical Center — Stanford, California, United States
- Vanderbilt Heart Institute — Nashville, Tennessee, United States
- Baylor Health — Plano, Texas, United States
- UVA — Charlottesville, Virginia, United States
- Sentara Norfolk — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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