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New heart procedure aims to stop persistent AFib without pills

NCT ID NCT03643224

Disease control Sponsor: Medtronic Cardiac Ablation Solutions Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called the DiamondTemp system, which uses heat energy to destroy tiny areas of heart tissue causing irregular heartbeats in people with persistent atrial fibrillation. 376 adults with drug-resistant symptoms took part. The goal was to see if the procedure could safely restore normal rhythm for at least a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiofrequency ablation catheter (DiamondTemp system)
What this could lead to
If successful, this could provide a safe and effective way to control persistent atrial fibrillation and reduce symptoms without long-term medication.
What could go wrong
This is a completed trial, but results may not apply to all patients. Risks include serious side effects like heart damage or stroke. The procedure may not permanently fix the condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

376 people

The number who actually took part.

Started

Sep 2018

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law. 2. Subjects with a history of documented symptomatic, persistent Atrial Fibrillation with 1) a physician's note documenting a continuous AF episode lasting longer than 7 days but less than 12 months AND 2) two electrocardiograms from any form of rhythm monitoring showing continuous AF taken at least 7 days apart OR a 24-hour Holter within 180 days of the ablation procedure showing continuous AF. 3. Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug. 4. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia. 5. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment. 6. Subject is willing and able to provide written consent. Exclusion Criteria: At time of enrollment and/or prior to procedure: 1. Continuous AF \>12 months (long-standing persistent AF) 2. Paroxysmal AF with longest episode \<7 days 3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause 4. Rheumatic heart disease 5. Severe mitral regurgitation 6. Hypertrophic cardiomyopathy 7. LA diameter \>5.5 cm 8. Left ventricular ejection fraction (LVEF) \<40% 9. Currently NYHA Class III or IV or exhibits uncontrolled heart failure 10. Body Mass Index (BMI) \>42 kg/m2. 11. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment 12. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation 13. Coagulopathy, bleeding diathesis or suspected procoagulant state 14. Sepsis, active systemic infection or fever (\>100.5 oF / 38 oC) within a week prior to the ablation procedure 15. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition 16. Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study. 17. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure. 18. Positive pregnancy test results for female subjects of childbearing potential or breast feeding. 19. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes. 20. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study. 21. Life expectancy \<12 months based on medical history or the medical judgement of the investigator. Within 1 month of enrollment or just prior to procedure: 22. Documented LA thrombus upon imaging 23. Creatinine \>2.5mg/dl or creatinine clearance \<30mL/min Within 3 months of enrollment: 24. Significant gastrointestinal (GI) bleed 25. Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention Within 6 months of enrollment: 26. Coronary artery bypass graft (CABG) procedure 27. Implant procedure performed for ICD, CRT leads or pacemaker 28. Documented stroke, CVA, TIA or suspected neurological event

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Persistent atrial fibrillation

Contacts and locations

Locations

  • Advent Health, Florida Hospital Orlando

    Orlando, Florida, 32751, United States

  • CHRU Nancy

    Nancy, 54511, France

  • Centro Cardiologico Monzino

    Milan, Milano, 20138, Italy

  • Clinique Pasteur

    Toulouse, 31076, France

  • Clinique Saint Pierre

    Perpignan, 66000, France

  • Clinique du Tonkin

    Villeurbanne, Lyon, 69100, France

  • Grandview Medical Center

    Birmingham, Alabama, 35242, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institut Klinicke a Experimentalni Mediciny (IKEM)

    Prague, Czechia, 14021, Czechia

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

    Québec, Quebec, G1V4G5, Canada

  • Iowa Heart Center

    West Des Moines, Iowa, 50266, United States

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216, United States

  • Kansas City Heart Rhythm Institute

    Overland Park, Kansas, 66211, United States

  • Keck School Of Medicine

    Los Angeles, California, 90033, United States

  • Leipzig Heart Institute GmbH

    Leipzig, 04289, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University Of South Carolina

    Charleston, South Carolina, 29425, United States

  • Montefiore Medical Center

    New York, New York, 10467, United States

  • Montreal Heart Institute

    Montreal, Quebec, HITC8, Canada

  • Na Homolce

    Prague, Prague, 15000, Czechia

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Ospedale dell'Angelo

    Venezia, 30174, Italy

  • Southlake Regional Health Center

    Newmarket, Ontario, L3Y2P6, Canada

  • St Ann's University Hospital

    Brno, 65691, Czechia

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • Trident Medical Center

    Charleston, South Carolina, 29406, United States

  • University Of Alabama

    Birmingham, Alabama, 35294, United States

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