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

AtriCure

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Ablation procedure staged catheter ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01661205

CP2012-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

AtriCure Bipolar System combined with a catheter ablation

Experimental group

Description:

Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart

Treatment:

Device: Ablation procedure staged catheter ablation