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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AtriCure Bipolar System combined with a catheter ablation

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

Group Type EXPERIMENTAL

Ablation procedure staged catheter ablation

Intervention Type DEVICE

AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart

Interventions

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Ablation procedure staged catheter ablation

AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No