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NCT Number: NCT03546374

Medtronic 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 atrial fibrillation (AF).

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Longstanding Persistent Atrial Fibrillation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Hospitals and Clinic, Palo Alto, California, United States

Loading trial locations.

About this study

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 United States (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias

Treatment and study plan

Surgical Ablation

Procedure

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.

Cardioblate and Cryoflex hand held devices

Device

The Cardioblate hand held devices consist of the Cardioblate iRF and Cryoflex surgical ablation devices.

Primary outcomes

  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 on Holter, and 10 seconds on 12-lead ECG after removal from antiarrhythmic drug (AAD) therapy.

Secondary outcomes

  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. Atrial Fibrillation Effect on QualiTy-of-life (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 Health Survey (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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Halverson

CONTACT

[email protected]

763-514-9765

Stephanie Yong

CONTACT

[email protected]

763-526-2032

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Surgery

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
Jun 6, 2018
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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