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

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01661205

Run by

AtriCure, Inc.

People needed

30

Starts

2012-08-01

Expected to finish

2015-12-01

Last updated by the study team

2017-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 year
• Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD).
• 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

You may not qualify if…

• Prior Cardiothoracic Surgery
• Patient has NYHA (New York Heart Association) 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

Where it is running

• Stanford University Medical Center — Stanford, California, United States
• Colorado Springs Cardiology/Colorado Cardiac Alliance — Colorado Springs, Colorado, United States
• Vanderbilt Heart Institute — Nashville, Tennessee, United States
• Sentara Norfolk Hospital — Norfolk, Virginia, United States
• Universitair Ziekenhuis Brussel — Brussels, Belgium
• Academic Medical Center — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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