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Heart device DiamondTemp under Real-World watch: will it deliver?

NCT ID NCT04735016

Knowledge-focused 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry follows 545 people with arrhythmia who received a heart ablation using the DiamondTemp system. Researchers will track how many stay free of their heart rhythm problem and how many have serious side effects over 12 months. The goal is to see how well the device works in everyday medical practice.

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 abnormal rhythms)
What this could lead to
If successful, this registry will confirm that the DiamondTemp system is safe and effective for routine use in treating arrhythmias.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection or other factors. It does not test a new treatment, only gathers real-world data.

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

About 545 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Mar 2031

An estimate. End dates often move.

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 (or minimum age as required by local regulations) 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: * Subject is ≥ 18 years of age or minimum age as required by local regulations * Planned procedure using commercially available DiamondTemp™ Ablation System * Willing to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements Exclusion Criteria: * Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager * Subject with exclusion criteria required by local law

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease

As listed by the trial registrant

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

Arrhythmia

Contacts and locations

Locations

  • CHRU de Tours - Hôpital Trousseau

    Chambray-lès-Tours, 37170, France

  • Capio - Clinique du Tonkin

    Villeurbanne, 69300, France

  • Catharina Ziekenhuis

    Eindhoven, 5623, Netherlands

  • Fiona Stanley Hospital

    Murdoch, 6150, Australia

  • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

    Bad Oeynhausen, 32545, Germany

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital de Santa Marta

    Lisbon, 1169-024, Portugal

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08025, Spain

  • Humanitas Mater Domini

    Castellanza, 21053, Italy

  • Inselspital - Universitätsspital Bern

    Bern, 3010, Switzerland

  • John Paul II Upper Silesian Medical Centre

    Katowice, 40-752, Poland

  • Ospedale dell'Angelo

    Venezia, 21053, Italy

  • Ospedale di Conegliano - S. Maria dei Battuti

    Conegliano, 31015, Italy

  • Royal Sussex County Hospital

    Brighton, BN2 5BE, United Kingdom

  • Saint Vincenz Krankenhaus Paderborn

    Paderborn, 33098, Germany

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3435 CM, Netherlands

  • Sunshine Coast University Hospital

    Birtinya, QLD 4757, Australia

  • Universitair Ziekenhuis Brussel

    Jette, 1090, Belgium

  • University Hospitals Coventry & Warwickshire

    Coventry, CV2 2DX, United Kingdom

  • University Medical Centre Ljubljana

    Ljubljana, 1000, Slovenia

  • Universitäres Herzzentrum

    Hamburg, 20246, Germany

More trials for these conditions

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