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

Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. 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 Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Hybrid: AtriCure Bipolar System & EP ablation procedure

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Heart Institute
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Health
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • UVA
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk

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:

1. Age > 18 years
2. Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
3. Patient is willing and able to provide written informed consent.
4. Patient has a life expectancy of at least 2 years.
5. Patient is willing and able to attend the scheduled follow-up visits.

Exclusion Criteria:

1. Prior Cardiothoracic Surgery.
2. Patient has NYHA Class IV heart failure.
3. Evidence of underlying structural heart disease requiring surgical treatment.
4. Ejection fraction < 30%
5. Measured left atrial diameter > 6.0 cm
6. Renal Failure
7. Stroke within previous 6 months.
8. Known carotid artery stenosis greater than 80%.
9. Evidence of significant active infection or endocarditis.
10. Pregnant woman or women desiring to become pregnant in the next 24 months.
11. Presence of thrombus in the left atrium determined by echocardiography.
12. History of blood dyscrasia.
13. Contraindication to anticoagulation, based on Investigator's opinion.
14. Mural thrombus or tumor.
15. 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; procedure using the AtriCure Bipolar System plus a catheter ablation	Device: Hybrid: AtriCure Bipolar System & EP ablation procedure; AtriCure Bipolar System plus a catheter ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint	Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.	Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
Absence of Atrial Fibrillation	Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.	12 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Serious Device or Procedure Related Adverse Event Rate		12 month follow-up
Acute Procedure Success		Upon completion of the index procedure, up to ten hours
Absence of Atrial Fibrillation	Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.	After the 3 month blanking period through twelve month follow-up.
Number of Participants With Reintervention to Address Atrial Dysrhythmia	Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months	12 months
Number of Participants With DC Cardioversion		12 months
Improvement in AF	Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0)	12 months
Duration of Procedure		During index procedure

Collaborators and Investigators

• Sponsor: AtriCure, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (Estimate): November 23, 2010

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Ablation; Catheter ablation; Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CP2009-1