Medtronic Terminate AF Study
Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
1 other identifier
interventional
160
1 country
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2018
CompletedFirst Posted
Study publicly available on registry
June 6, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMarch 5, 2026
March 1, 2026
5.9 years
May 9, 2018
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Composite acute major adverse event rate
Composite acute major adverse event rate including: Atrial tears, Esophageal injury, Excessive bleeding, Mediastinitis, Myocardial infarction (MI), Pulmonary embolism, Peripheral arterial embolism, Stroke, Transient ischemic attacks (TIA), Death.
30-days post-procedure or hospital discharge (whichever is longer)
Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Freedom from AF/AFL/AT of 30 seconds or greater duration on Holter, and 10 seconds on 12-lead ECG after removal from antiarrhythmic drug (AAD) therapy.
6-months post-procedure to 12-months post-procedure
Secondary Outcomes (9)
Composite acute major adverse event rate (Safety)
6-months post-procedure
Composite acute major adverse event rate (Safety)
12-months post-procedure
Percentage of new permanent pacemaker implantation (Safety)
12-months post-procedure
Acute procedural success (Efficacy)
During index procedure
Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)
6-months post-procedure
- +4 more secondary outcomes
Study Arms (1)
Primary Cohort
EXPERIMENTALPatients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery
Interventions
The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.
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.
Eligibility Criteria
You may qualify if:
- History of non-paroxysmal AF (persistent or longstanding persistent)
- Concomitant indication for non-emergent open-heart surgery, eg,
- Coronary artery bypass grafting
- Valve repair or replacement
- Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Stanford Hospitals and Clinic
Palo Alto, California, 94304, United States
Adventist Health St. Helena
St. 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
St 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph J Damiano, MD
Washington University School of Medicine
Central Study Contacts
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
May 9, 2018
First Posted
June 6, 2018
Study Start
November 15, 2018
Primary Completion
October 1, 2024
Study Completion (Estimated)
December 1, 2026
Last Updated
March 5, 2026
Record last verified: 2026-03