NCT04735016

Brief Summary

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
59mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
12 countries

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Apr 2021Mar 2031

First Submitted

Initial submission to the registry

January 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 22, 2021

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

9.9 years

First QC Date

January 28, 2021

Last Update Submit

February 2, 2026

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (2)

  • Freedom from Recurrence at 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

    Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months.

    12 Months

Study Arms (1)

Treatment Arm

Patients enrolled and treated with the DiamondTemp™ Ablation System

Device: DiamondTemp™ Ablation System

Interventions

DiamondTemp™ Ablation SystemDEVICE

A cardiac ablation will be performed using the DiamondTemp™ Ablation System.

Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Sunshine Coast University Hospital

Birtinya, QLD 4757, Australia

ACTIVE NOT RECRUITING

Fiona Stanley Hospital

Murdoch, 6150, Australia

ACTIVE NOT RECRUITING

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

COMPLETED

CHRU de Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170, France

COMPLETED

Capio - Clinique du Tonkin

Villeurbanne, 69300, France

COMPLETED

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

COMPLETED

Universitäres Herzzentrum

Hamburg, 20246, Germany

COMPLETED

Saint Vincenz Krankenhaus Paderborn

Paderborn, 33098, Germany

COMPLETED

Humanitas Mater Domini

Castellanza, 21053, Italy

ACTIVE NOT RECRUITING

Ospedale di Conegliano - S. Maria dei Battuti

Conegliano, 31015, Italy

COMPLETED

Ospedale dell'Angelo

Venezia, 21053, Italy

COMPLETED

Catharina Ziekenhuis

Eindhoven, 5623, Netherlands

COMPLETED

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, 3435 CM, Netherlands

COMPLETED

John Paul II Upper Silesian Medical Centre

Katowice, 40-752, Poland

COMPLETED

Hospital de Santa Marta

Lisbon, 1169-024, Portugal

RECRUITING

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

COMPLETED

Hospital de la Santa Creu I Sant Pau

Barcelona, 08025, Spain

COMPLETED

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

COMPLETED

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

COMPLETED

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

COMPLETED

University Hospitals Coventry & Warwickshire

Coventry, CV2 2DX, United Kingdom

COMPLETED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Josman Suri

CONTACT

7635050262josman.suri@medtronic.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 2, 2021

Study Start

April 22, 2021

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Last Updated

February 3, 2026

Record last verified: 2026-02

Locations

ES(2)NL(2)DE(3)IT(3)PT(1)PL(1)GB(2)BE(1)SL(1)FR(2)CH(1)AU(2)