Medtronic Terminate AF Study

October 20, 2023 updated by: Medtronic Cardiac Surgery

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
      • Saint Helena, California, United States, 94574
        • Recruiting
        • Adventist Health St. Helena
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06102
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Recruiting
        • St Vincent Heart Center of Indiana
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
    • Ohio
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Contact:
    • Utah
      • Murray, Utah, United States, 84107
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98122
      • Seattle, Washington, United States, 98101
      • Tacoma, Washington, United States, 98405
        • Withdrawn
        • St. Joseph Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: 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.
Device: Cardioblate and Cryoflex hand held devices
The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite acute major adverse event rate
Time Frame: 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.
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite acute major adverse event rate (Safety)
Time Frame: 6-months post-procedure
Composite acute major adverse event rate at 6 months post-procedure (as defined above)
6-months post-procedure
Composite acute major adverse event rate (Safety)
Time Frame: 12-months post-procedure
Composite acute major adverse event rate at 12 months post-procedure (as defined above)
12-months post-procedure
Percentage of new permanent pacemaker implantation (Safety)
Time Frame: 12-months post-procedure
Percentage of new permanent pacemaker implantation presented by indication
12-months post-procedure
Acute procedural success (Efficacy)
Time Frame: During index procedure
Acute procedural success (pulmonary vein isolation)
During index procedure
Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)
Time Frame: 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
6-months post-procedure
Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy)
Time Frame: 6-months post-procedure
Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 6 months post-procedure
6-months post-procedure
Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy)
Time Frame: 12-months post-procedure
Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 12 months post-procedure
12-months post-procedure
AFEQT Quality of Life Score over time (Efficacy)
Time Frame: 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.
12-months post-procedure
SF-12 Quality of Life Score over time (Efficacy)
Time Frame: 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.
12-months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Surgery

Investigators

  • Principal Investigator: Ralph J Damiano, MD, 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 Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

June 1, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT17066ECT001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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