Clinical trial NCT01661205: Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
Official title: Feasibility Trial of a Staged Epicardial & Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Persistent AF
Longstanding Persistent AF
Ablation
catheter ablation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
timeFrame: 30 days post-index procedure or hospital discharge
measure: Number of Subjects With Absence of Atrial Fibrillation
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Number Subjects With Serious Device or Procedure Related Adverse Event Rate
timeFrame: 12 month follow-up
measure: Number of Subjects With Acute Procedure Success
timeFrame: Day 0
measure: Number of Subject Without Atrial Fibrillation
timeFrame: 6 and 12 month follow-up
measure: Number of Subjects With Reinterventions
timeFrame: 12 month follow-up
measure: Number of Subjects With Direct Current (DC) Cardioversion
timeFrame: 12 month follow-up
measure: Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Cardiology/Colorado Cardiac Alliance
state: Colorado
city: Nashville
country: United States
facility: Vanderbilt Heart Institute
state: Tennessee
city: Norfolk
country: United States
facility: Sentara Norfolk Hospital
state: Virginia
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
References: