Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:December 2015

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Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation

The purpose of this study is to assess the safety and technical feasibility of treating
subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar
System, with mapping and additional lesion creation/ gap closure (as needed) provided by
currently approved catheter technology, when the epicardial and endocardial phases are
performed in a staged manner within 1-10 days apart, during the same hospitalization.

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac
surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure
performed approximately 1-10 days after, in treating atrial fibrillation, and how effective
is this staged procedure. 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:

- Age > 18 year

- Patients with symptomatic persistent or longstanding persistent AF refractory to a
minimum of one Class I or III AAD(s).

- Patients with failed catheter ablation attempts are eligible if the patients are
symptomatic with persistent or longstanding persistent AF. (catheter ablation
procedure must be more than 3 months prior to index procedure)

- Life expectancy of at least two years

- Patient will and able to provide informed consent

- Patient is willing and able to attend the scheduled follow-up visits

Exclusion Criteria:

- Prior Cardiothoracic Surgery

- Patient has NYHA Class IV heart failure

- Evidence of underlying structural heart disease requiring surgical treatment

- Surgical procedure within the 30 days prior to the index procedure

- 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
We found this trial at
5
sites
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Brussel,
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from
Colorado Springs, CO
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Nashville, Tennessee 37232
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from
Nashville, TN
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Norfolk, Virginia 23507
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from
Norfolk, VA
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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mi
from
Stanford, CA
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