DiamondTemp Global Registry

May 22, 2026 updated by: Medtronic Cardiac Ablation Solutions
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the commercially available DiamondTemp™ Family of Cardiac Ablation Catheters (hereafter referred to as the DiamondTemp™ Ablation System) and followed according to the standard of care at each respective institution. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Study Type

Observational

Enrollment (Estimated)

545

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Birtinya, Australia, QLD 4757
        • Sunshine Coast University Hospital
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
  • Belgium
      • Jette, Belgium, 1090
        • Universitair Ziekenhuis Brussel
  • France
      • Chambray-lès-Tours, France, 37170
        • CHRU de Tours - Hopital Trousseau
      • Villeurbanne, France, 69300
        • Capio - Clinique du Tonkin
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
      • Hamburg, Germany, 20246
        • Universitäres Herzzentrum
      • Paderborn, Germany, 33098
        • Saint Vincenz Krankenhaus Paderborn
  • Italy
      • Castellanza, Italy, 21053
        • Humanitas Mater Domini
      • Conegliano, Italy, 31015
        • Ospedale di Conegliano - S. Maria dei Battuti
      • Venezia, Italy, 21053
        • Ospedale dell'Angelo
  • Netherlands
      • Eindhoven, Netherlands, 5623
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis Nieuwegein
  • Poland
      • Katowice, Poland, 40-752
        • John Paul II Upper Silesian Medical Centre
  • Portugal
      • Lisbon, Portugal, 1169-024
        • Hospital de Santa Marta
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital - Universitätsspital Bern
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry & Warwickshire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Arm
Patients enrolled and treated with the DiamondTemp™ Ablation System
Device: DiamondTemp™ Ablation System
A cardiac ablation will be performed using the DiamondTemp™ Ablation System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from Recurrence at 12 Months
Time Frame: 12 Months
Estimate the 12-month freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the DiamondTemp™ Ablation System.
12 Months
Freedom from Device / Procedure Related Adverse Events
Time Frame: 12 Months
Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Ablation Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2021

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT20059

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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