AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment

NCT03732794 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CP2018-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 15

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with Left Atrial Appendage (LAA) exclusion using the AtriClip device.

Conditions

Atrial Fibrillation (AF); Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)

  Freedom from AF/AFL/AT lasting \>30 seconds in duration 6 through 12-months following the ablation procedure in the absence of Class I or III antiarrhythmic drugs (AADs).

  12 months

• Safety Endpoint: composite acute major adverse event (MAE) rate

  The composite acute major adverse event (MAE) rate, within 30-days post-procedure and deaths after 30-days if death is procedure related.

  30 days

Secondary Outcomes (7)

• Composite post-procedure MAE rate (Safety).

  12 months

• Pacemaker implantation (Safety).

  12 months

• Overall Serious Adverse Event (SAE) rate (Safety)

  12 months

• Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness)

  12 months

• Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness)

  12 months

Study Arms (1)

AtriCure CryoICE & AtriClip LAA Exclusion

EXPERIMENTAL

AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.

Device: AtriCure CryoICE & AtriClip LAA Exclusion

Interventions

AtriCure CryoICE & AtriClip LAA Exclusion DEVICE

AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.

AtriCure CryoICE & AtriClip LAA Exclusion

Eligibility Criteria

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

You may qualify if:

• Subject is greater than or equal to 18 years of age
• Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/ European Cardiac Arrhythmia Society (ECAS) Guidelines
• Stable Subject that is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Tricuspid valve repair or replacement, and Coronary artery bypass procedures
• Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
• Subject is willing and able to provide written informed consent
• Subject has a life expectancy of at least 5 years
• Subject is willing and able to return for scheduled follow-up visits.

You may not qualify if:

• Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
• Previous surgical Maze procedure
• Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry
• Prior cardiac surgery (Redo)
• Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or patent foramen ovale repair, and/or atrial septal defect repair.
• Class IV New York Heart Association (NYHA) heart failure symptoms
• Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurological deficit
• Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
• Need for emergent cardiac surgery (i.e. cardiogenic shock)
• Known carotid artery stenosis greater than 80%
• Documented AF duration of greater than ten years
• LA diameter \>7 cm by Transthoracic echocardiography (TTE)
• Current diagnosis of active systemic infection
• Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
• Renal failure requiring dialysis or hepatic failure

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (15)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Washington Adventist Hospital

Washington D.C., District of Columbia, 20912, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Franciscan Health

Indianapolis, Indiana, 46237, United States

Location

Deaconess Gateway Hospital

Newburgh, Indiana, 47630, United States

Location

University Of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Mount Sinai Icahn School of Medicine

New York, New York, 10029, United States

Location

NYP-Weill Cornell

New York, New York, 10065, United States

Location

Northwell Health Systems

New York, New York, 10075, United States

Location

St. Joseph Hospital Health Center

Syracuse, New York, 13203, United States

Location

St Thomas West Hospital

Nashville, Tennessee, 37205, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Niv Ad, MD

  Washington Adventist Hospital

  PRINCIPAL INVESTIGATOR

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: November 5, 2018
• First Posted: November 7, 2018
• Study Start: January 30, 2019
• Primary Completion: June 27, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Information will be available in accordance with clinical trials.gov requirements.
• Access Criteria: Publicly available through clinical trials.gov

Locations

US (15)