Medtronic Terminate AF Study

Description

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 AF.

Conditions

Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

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Study Overview

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Study Details

Study overview

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 AF.

Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)

Medtronic Terminate AF Study

Condition
Persistent Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford Hospitals and Clinic, Palo Alto, California, United States, 94304

Saint Helena

Adventist Health St. Helena, Saint Helena, California, United States, 94574

Hartford

Hartford Healthcare, Hartford, Connecticut, United States, 06102

Indianapolis

St Vincent Heart Center of Indiana, Indianapolis, Indiana, United States, 46290

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Grand Rapids

Spectrum Health Hospitals, Grand Rapids, Michigan, United States, 49503

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Toledo

ProMedica Toledo, Toledo, Ohio, United States, 43606

Pittsburgh

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States, 15212

Wynnewood

Lankenau Medical Center, Wynnewood, Pennsylvania, United States, 19096

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * Wolff-Parkinson-White syndrome
  • * NYHA Class = IV
  • * Left Ventricular Ejection Fraction ≤ 30%
  • * Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
  • * Previous AF ablation, 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Cardiac Surgery,

Ralph J Damiano, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2026-12