Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach

NCT02393885 | Completed Results DMC FDA Device

• 1 other identifier: CP2014-1
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 17

Brief Summary

The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation

Conditions

Atrial Fibrillation; Persistent or Longstanding Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint

  Freedom from any documented AF, atrial flutter, or atrial tachycardia lasting \>30 seconds in duration through the 12 month follow-up visit in the absence of Class I or III AADs (with the exception of previously failed AADs at doses not exceeding those previously failed).

  6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit

• Primary Safety Endpoint

  The primary safety endpoint is a composite endpoint consisting of any one or more of the events if they were adjudicated by the CEC to be serious adverse events (SAEs) and related to device/procedures as follows: 1. The AtriCure Bipolar System and/or the AtriClip Pro LAA Exclusion System, within 30 days following the epicardial surgical ablation procedure; or 2. The epicardial surgical ablation procedure within 30 days following the epicardial procedure; or 3. The endocardial index procedure (or a repeat endocardial ablation procedure performed during the blanking period) within 7 days following an endocardial ablation procedure.

  30 Days

Study Arms (1)

AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System

EXPERIMENTAL

AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure.

Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation

Interventions

AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation DEVICE

Also known as: Irrigated Endocardial Catheters

AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation refractory to a minimum of one Class I or Class III AADs.

You may not qualify if:

• AF \>10 years.
• Refractory hypertension, defined as systolic (\>150 mm Hg) or diastolic (\> 90 mm Hg) blood pressure that remains uncontrolled despite sustained therapy
• History of pulmonary hypertension
• Pulmonary vein stenosis in one or more of the pulmonary veins
• EP catheter ablation procedure to treat atrial fibrillation within 3 months
• Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a pneumothorax or hemothorax.
• Sleep apnea, home oxygen therapy, moderate to severe COPD, (FEV1/FVC \< 70% predicted) or patient is considered intolerant to single lung ventilation.
• NYHA Class IV heart failure.
• Uncorrected, reversible cause(s) of atrial fibrillation, or is currently being treated for arrhythmias other than atrial fibrillation (AF) or atrial flutter.
• Documented history of previous catheter ablation with perforation, history of pericarditis, pericardial effusion, or tamponade.
• Structural heart disease requiring surgical treatment (i.e. valve disease requiring repair or replacement within 12 months following surgical ablation procedure).
• CAD requiring intervention (either surgical, i.e. CABG, or catheter).
• Ejection fraction \< 30%
• Measured left atrial diameter \> 5.5 cm
• Stroke/cerebrovascular accident (CVA) within previous six months, carotid artery stenosis greater than 80%.

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (17)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Cedars-Sinai Heart Institute

Los Angeles, California, 90048, United States

Location

Alta Bates Sutter Medical Center, East Bay Hospital

Oakland, California, 94609, United States

Location

St. Helena Hospital, Adventist Heart Institute

St. Helena, California, 94574, United States

Location

Stanford University Department of CV medicine

Stanford, California, 94305, United States

Location

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

Orlando Heart Institute

Orlando, Florida, 32806, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals

Cincinnati, Ohio, United States

Location

Pinnacle Health

Harrisburg, Pennsylvania, 17104, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Aspirus Research Institute

Wausau, Wisconsin, 54401, United States

Location

Universitair Ziekenhuis Brussel (UZ Brussels)

Brussels, Belgium

Location

Academic Medical Center (AMC)

Amsterdam, Netherlands

Location

Related Publications (1)

• Ellenbogen KA, Khoynezhad A, La Meir M, de Asmundis C, Koneru JN, Johnkoski J, Rist K, Mumtaz M, Link MG, de Groot JR, Driessen AHG, Lee MY, Hoff SJ, Bello D, Dunnington G, Eisenberg S, Vloka M, Taylor BJ, Jones SD, Philpott JM, Beaver TM, Miles WM, Khan JH, Kang S, Gandhi GD, Okum EJ, Badhwar N, Baykaner T, Lee AM, Vesco PA, Smith JM, Gaynor S, Frazier K, Lee RJ, Kasirajan V. Dual Epicardial and Endocardial Procedure (DEEP) for Persistent or Longstanding Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2025 Oct;18(10):e013692. doi: 10.1161/CIRCEP.125.013692. Epub 2025 Sep 30.

  PMID: 41025224 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nfii Ndikintum
• Organization: AtriCure, Inc.

nndikintum@atricure.com

1-513-755-4100

Study Officials

• Kenneth Ellenbogen, MD

  VCU

  PRINCIPAL INVESTIGATOR

• Vigneshwar Kasirajan, MD

  VCU

  PRINCIPAL INVESTIGATOR

• Ali Khoynezhad, MD

  MemorialCare Long Beach Medical Ctr

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: February 1, 2015
• Primary Completion: March 28, 2022
• Study Completion: April 17, 2024
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-05

Locations

US (15); NL (1); BE (1)