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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Ablation procedure staged catheter ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium
    • Universitair Ziekenhuis Brussel
• Netherlands
  • Amsterdam, Netherlands
    • Academic Medical Center
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Cardiology/Colorado Cardiac Alliance
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Heart Institute
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Ablation procedure staged catheter ablation; AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.	Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.	30 days post-index procedure or hospital discharge
Number of Subjects With Absence of Atrial Fibrillation	Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.	12 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number Subjects With Serious Device or Procedure Related Adverse Event Rate		12 month follow-up
Number of Subjects With Acute Procedure Success	Defined as subject meeting all of the following criteria upon completion of the index-EP procedure; Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);; Bi-directional cavotricuspid isthmus block;; Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);; Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.	Day 0
Number of Subject Without Atrial Fibrillation	AF free with or without the need of antiarrhythmic drugs	6 and 12 month follow-up
Number of Subjects With Reinterventions		12 month follow-up
Number of Subjects With Direct Current (DC) Cardioversion		12 month follow-up
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores	Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.; This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.; The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.; Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .	12 month follow-up

Collaborators and Investigators

• Sponsor: AtriCure, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: August 6, 2012
• First Posted (Estimate): August 9, 2012

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Ablation; catheter ablation; Persistent AF; Longstanding Persistent AF
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CP2012-1