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Heart device study halted early – what we know

NCT ID NCT05230524

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This study looked at how well the DiamondTemp ablation system controls atrial fibrillation (a type of irregular heartbeat) over three years. It included 84 adults with paroxysmal AF who had not responded to medication. The study was terminated early, so the full results are not available.

What this could mean

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

Active substance
DiamondTemp™ Ablation System (a device that uses heat to destroy heart tissue causing irregular heartbeat)
What this could lead to
If successful, this could confirm that the DiamondTemp system is a safe and effective way to control atrial fibrillation for years.
What could go wrong
The study was terminated early, so results are limited. It is observational, not randomized, and may not prove the device is better than other treatments.

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.

Participants

84 people

The number who actually took part.

Started

Feb 2022

Finished

Dec 2025

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.

Who is studied

Subjects ≥ 18 years of age who have a recommendation for an ablation with the DiamondTemp™ Ablation System may be approached regarding enrollment in this study.

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. A diagnosis of recurrent symptomatic paroxysmal AF 2. Failure or intolerance of at least one Class I or III antiarrhythmic drug (including sotalol) 3. Patient is ≥ 18 years of age 4. Planned procedure for the treatment of AF using commercially available DiamondTemp™ Ablation System 5. Patient is willing and able to provide written informed consent 6. Patient is willing and able to comply with study requirements Exclusion Criteria: 1. Prior persistent AF (continuous AF that is sustained \>7 days) 2. Patient with life expectancy that makes it unlikely 36 months of follow-up will be completed. 3. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic 4. Patients with contraindications to a Holter monitor 5. Unwilling or unable to comply fully with study procedures and follow-up

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

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

Paroxysmal atrial fibrillation

Contacts and locations

Locations

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

    Ancona, 60030, Italy

  • Centre Hospitalier de Pau - Hôpital François Mitterrand

    Pau, 64046, France

  • Florida Electrophysiology LLC

    Winter Park, Florida, 32792, United States

  • Humanitas Mater Domini

    Varese, 21053, Italy

  • Reunion University Hospital - Saint Pierre

    Saint-Pierre, 97448, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.