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Medtronic Terminate AF Study

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ClinicalTrials.gov Identifier: NCT03546374
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

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.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Longstanding Persistent Atrial Fibrillation Procedure: Surgical Ablation Device: Cardioblate and Cryoflex hand held devices Not Applicable

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 15 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 non-paroxysmal atrial fibrillation to the product labeling.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primary Cohort
Patients with a history of non-paroxysmal atrial fibrillation (persistent or longstanding persistent) 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.




Primary Outcome Measures :
  1. 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.

  2. 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 after removal from antiarrhythmic drug (AAD) therapy.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Percentage of new permanent pacemaker implantation (Safety) [ Time Frame: 12-months post-procedure ]
    Percentage of new permanent pacemaker implantation presented by indication

  4. Acute procedural success (Efficacy) [ Time Frame: During index procedure ]
    Acute procedural success (pulmonary vein isolation)

  5. 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. 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

  7. 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

  8. 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.


  9. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. History of non-paroxysmal AF (persistent or longstanding persistent)
  2. Concomitant indication for non-emergent open-heart surgery, eg,

    1. Coronary artery bypass grafting
    2. Valve repair or replacement
  3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546374


Contacts
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Contact: Lauri Eakins 763-514-9851 lauri.eakins@medtronic.com
Contact: Ryan Palmer 763-514-9732 ryan.j.palmer@medtronic.com

Locations
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United States, California
Stanford Hospitals and Clinic Recruiting
Palo Alto, California, United States, 94304
Contact: Anson Lee, MD       ansonlee@stanford.edu   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ralph J Damiano, MD       damianor@wustl.edu   
United States, Ohio
ProMedica Toledo Recruiting
Toledo, Ohio, United States, 43606
Contact: Michael Moront, MD    419-291-2077    Michael.Moront@promedica.org   
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Stephen Bailey, MD    412-359-8820    stephen.bailey@ahn.org   
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: John Doty, MD       John.Doty@imail.org   
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jonathan Philpott, MD       jmphilpo@sentara.com   
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Eric Lehr, MD    206-320-7300    Eric.Lehr@swedish.org   
St. Joseph Medical Center Recruiting
Tacoma, Washington, United States, 98405
Contact: John Luber, MD    253-426-6882    JohnLuber@chifranciscan.org   
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
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Principal Investigator: Ralph J Damiano, MD Washington University School of Medicine

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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT03546374     History of Changes
Other Study ID Numbers: MDT17066ECT001
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes