Medtronic Terminate AF Study

Not Applicable

Recruiting

• Conditions: Longstanding Persistent Atrial Fibrillation; Persistent Atrial Fibrillation

• Registration Number: NCT03546374
• Lead Sponsor: Medtronic Cardiac Surgery

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 AF.

Detailed Description

This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the US. The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months.

The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-06
• Study Start: 2018-11-15
• Primary Completion: 2024-10-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Composite acute major adverse event rate (Safety)	12-months post-procedure	Composite acute major adverse event rate at 12 months post-procedure (as defined above)
Percentage of new permanent pacemaker implantation (Safety)	12-months post-procedure	Percentage of new permanent pacemaker implantation presented by indication
Acute procedural success (Efficacy)	During index procedure	Acute procedural success (pulmonary vein isolation)
Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy)	6-months post-procedure	Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 6 months post-procedure
SF-12 Quality of Life Score over time (Efficacy)	12-months post-procedure	Characterization of quality of life scores over time as assessed by SF-12 questionnaire.; SF-12 overall score ranges from 0-100. Zero indicates the lowest level of health measured by the scale and 100 indicates the highest level of health.; The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval.
Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)	6-months post-procedure	Freedom from AF/AFL/AT of 30 seconds or greater duration after removal from AAD therapy as assessed from the end of the 3-month blanking period through 6 months post-procedure
Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy)	12-months post-procedure	Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 12 months post-procedure
AFEQT Quality of Life Score over time (Efficacy)	12-months post-procedure	Characterization of quality of life scores over time as assessed by AFEQT questionnaire.; AFEQT overall score ranges from 0-100. Zero corresponds to complete disability and 100 corresponds to no disability.; The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval.

Trial Locations

Locations (15)

Stanford Hospitals and Clinic; 🇺🇸 Palo Alto, California, United States

Adventist Health St. Helena; 🇺🇸 Saint Helena, California, United States

Hartford Healthcare; 🇺🇸 Hartford, Connecticut, United States

St Vincent Heart Center of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Corewell Health; 🇺🇸 Grand Rapids, Michigan, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

ProMedica Toledo; 🇺🇸 Toledo, Ohio, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Lankenau Medical Center; 🇺🇸 Wynnewood, Pennsylvania, United States

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