RECRUITING

Medtronic Terminate AF Study

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Conditions

Persistent Atrial FibrillationLongstanding Persistent Atrial Fibrillation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 atrial fibrillation (AF).

Official Title

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

Quick Facts

Study Start:2018-11-15
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03546374

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of non-paroxysmal AF (persistent or longstanding persistent)
  2. * Concomitant indication for non-emergent open-heart surgery, eg,
  3. 1. Coronary artery bypass grafting
  4. 2. Valve repair or replacement
  5. * Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)
  1. * Wolff-Parkinson-White syndrome
  2. * New York Heart Association (NYHA) Class = IV
  3. * Left Ventricular Ejection Fraction ≤ 30%
  4. * Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
  5. * Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Maze procedure
  6. * Contraindication for anticoagulation therapy
  7. * Left atrial diameter \> 6.0 cm
  8. * Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  9. * Renal failure requiring dialysis or hepatic failure
  10. * Life expectancy of less than 1 year
  11. * Predicted risk of operative mortality \>10% as assessed by STS Risk Calculator
  12. * Pregnancy or desire to be pregnant within 12 months of the study treatment
  13. * Current diagnosis of active systemic infection
  14. * Active endocarditis
  15. * Documented MI 30 days prior to study enrollment
  16. * Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias

Contacts and Locations

Study Contact

Stephanie Yong
CONTACT
763-526-2032
stephanie.yong@medtronic.com
Jessica Halverson
CONTACT
763-514-9765
Jessica.halverson@medtronic.com

Principal Investigator

Ralph J Damiano, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Stanford Hospitals and Clinic
Palo Alto, California, 94304
United States
Adventist Health St. Helena
Saint Helena, California, 94574
United States
Hartford Healthcare
Hartford, Connecticut, 06102
United States
St Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Corewell Health
Grand Rapids, Michigan, 49503
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
ProMedica Toledo
Toledo, Ohio, 43606
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
Virginia Mason Heart Institute
Seattle, Washington, 98101
United States
Swedish Medical Center
Seattle, Washington, 98122
United States
St. Joseph Medical Center
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Medtronic Cardiac Surgery

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-15
Study Completion Date2026-12

Study Record Updates

Study Start Date2018-11-15
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Persistent Atrial Fibrillation
  • Longstanding Persistent Atrial Fibrillation