Recruiting

Medtronic

Sponsor:

Medtronic Cardiac Surgery

Code:

NCT03546374

Conditions

Persistent Atrial Fibrillation

Longstanding Persistent Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgical Ablation

Cardioblate and Cryoflex hand held devices

Study Details

Brief summary:

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).

Conditions

Persistent Atrial Fibrillation

Longstanding Persistent Atrial Fibrillation

Study ID

NCT03546374

Start date

Nov 15, 2018

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct 1, 2024

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • History of non-paroxysmal AF (persistent or longstanding persistent)
  • Concomitant indication for non-emergent open-heart surgery, eg,

1. Coronary artery bypass grafting
2. Valve repair or replacement
  • Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)

Exclusion Criteria:

  • Wolff-Parkinson-White syndrome
  • New York Heart Association (NYHA) Class = IV
  • Left Ventricular Ejection Fraction ≤ 30%
  • Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
  • Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Maze procedure
  • Contraindication for anticoagulation therapy
  • Left atrial diameter > 6.0 cm
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  • Renal failure requiring dialysis or hepatic failure
  • Life expectancy of less than 1 year
  • Predicted risk of operative mortality >10% as assessed by STS Risk Calculator
  • Pregnancy or desire to be pregnant within 12 months of the study treatment
  • Current diagnosis of active systemic infection
  • Active endocarditis
  • Documented MI 30 days prior to study enrollment
  • Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias

Study Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Primary Cohort

Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery

Interventions

Surgical Ablation

In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.

Cardioblate and Cryoflex hand held devices

The Cardioblate hand held devices consist of the Cardioblate iRF and Cryoflex surgical ablation devices.

Primary outcome measure

  • Composite acute major adverse event rate [ Time Frame: 30-days post-procedure or hospital discharge (whichever is longer) ]
  • Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT) [ Time Frame: 6-months post-procedure to 12-months post-procedure ]

Central Contacts and Locations

Central contacts

Stephanie Yong

763-526-2032stephanie.yong@medtronic.com

Jessica Halverson

763-514-9765Jessica.halverson@medtronic.com

Locations

St Vincent Heart Center of Indiana

Recruiting

Indianapolis, Indiana, United States, 46290

Contacts

David Heimansohn, MD

heimansohn@mac.com

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Serguei Melnitchouk, MD

smelnitchouk@mgh.harvard.edu

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Edward Murphy, MD

edward.murphy@spectrumhealth.org

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Ralph J Damiano, MD

damianor@wustl.edu

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Stephen Bailey, MD

stephen.bailey@ahn.org

Virginia Mason Heart Institute

Recruiting

Seattle, Washington, United States, 98101

Contacts

Robert Moraca, MD

Bob.Moraca@Virginiamason.org

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Eric Lehr, MD

Eric.Lehr@swedish.org

More Information

Sponsor

Medtronic Cardiac Surgery

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medtronic Cardiac Surgery on 2026-05-14.