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Persistent Atrial FibrillationNCT03546374

Medtronic Terminate AF Study

A study testing Surgical Ablation and Cardioblate and Cryoflex hand held devices in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by Medtronic Cardiac Surgery at 15 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surgical Ablation and Cardioblate and Cryoflex hand held devices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
15 sitesUnited States
Study dates
15 Nov 2018to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephanie Yong contact

763-526-2032

stephanie.yong@medtronic.com

Jessica Halverson contact

763-514-9765

Jessica.halverson@medtronic.com

15 sites in 1 country

United States15 sites, 7 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Serguei Melnitchouk, MD, smelnitchouk@mgh.harvard.edu

    Recruiting

  • Corewell Health

    Grand Rapids, Michigan, 49503

    Edward Murphy, MD, edward.murphy@spectrumhealth.org

    Recruiting

  • Hartford Healthcare

    Hartford, Connecticut, 06102

    Completed

  • St Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290

    David Heimansohn, MD, heimansohn@mac.com

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Completed

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    Completed

  • Stanford Hospitals and Clinic

    Palo Alto, California, 94304

    Completed

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Stephen Bailey, MD, stephen.bailey@ahn.org

    Recruiting

  • Virginia Mason Heart Institute

    Seattle, Washington, 98101

    Robert Moraca, MD, Bob.Moraca@Virginiamason.org

    Recruiting

  • Swedish Medical Center

    Seattle, Washington, 98122

    Eric Lehr, MD, Eric.Lehr@swedish.org

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Ralph J Damiano, MD, damianor@wustl.edu

    Recruiting

  • Adventist Health St. Helena

    St. Helena, California, 94574

    Withdrawn

  • St. Joseph Medical Center

    Tacoma, Washington, 98405

    Withdrawn

  • ProMedica Toledo

    Toledo, Ohio, 43606

    Completed

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

    Completed

Other trials in United States

About this study

Official title: 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 atrial fibrillation (AF).

Read the 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 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.

Being tested
Surgical Ablation, Cardioblate and Cryoflex hand held devices
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical AblationProcedure or surgery

    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 devicesDevice

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

Study groups in NCT03546374
Study groupRoleWhat they receive
Primary CohortExperimentalPatients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery
Receives: Procedure: Surgical Ablation; Device: Cardioblate and Cryoflex hand held devices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30-days post-procedure or hospital discharge (whichever is longer)

  2. 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.

    Measured: 6-months post-procedure to 12-months post-procedure

Secondary outcomes (9)

  1. Composite acute major adverse event rate (Safety)

    Composite acute major adverse event rate at 6 months post-procedure (as defined above)

    Measured: 6-months post-procedure

  2. Composite acute major adverse event rate (Safety)

    Composite acute major adverse event rate at 12 months post-procedure (as defined above)

    Measured: 12-months post-procedure

  3. Percentage of new permanent pacemaker implantation (Safety)

    Percentage of new permanent pacemaker implantation presented by indication

    Measured: 12-months post-procedure

  4. Acute procedural success (Efficacy)

    Acute procedural success (pulmonary vein isolation)

    Measured: During index procedure

  5. Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)

    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

    Measured: 6-months post-procedure

  6. Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy)

    Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 6 months post-procedure

    Measured: 6-months post-procedure

  7. Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy)

    Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 12 months post-procedure

    Measured: 12-months post-procedure

  8. Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Quality of Life Score over time (Efficacy)

    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.

    Measured: 12-months post-procedure

  9. SF-12 Health Survey (SF-12) Quality of Life Score over time (Efficacy)

    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.

    Measured: 12-months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start15 Nov 2018
  3. Primary completion1 Oct 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03546374
Sponsor's protocol ID
MDT17066ECT001
Status last verified
May 2026
First submitted
9 May 2018
Last updated
14 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Damiano RJ, Philpott JM, Moront MG, Murphy ET, Bailey SH, Ramlawi B, Willekes C, Melnitchouk S, Heimansohn D, Hu Y, Lehr EJ. A prospective, multicenter trial of irrigated radiofrequency ablation and cryoablation to treat nonparoxysmal atrial fibrillation. J Thorac Cardiovasc Surg. 2026 Sep;172(3):556-564.e13. doi: 10.1016/j.jtcvs.2026.04.010. Epub 2026 May 4.

    PubMed 42092502

Questions about this trial

What is this clinical trial studying?

A study testing Surgical Ablation and Cardioblate and Cryoflex hand held devices in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by Medtronic Cardiac Surgery at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephanie Yong (763-526-2032, stephanie.yong@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite acute major adverse event rate (time frame: 30-days post-procedure or hospital discharge (whichever is longer)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03546374, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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