DiamondTemp Global Registry

NCT04735016 · tracked via the Priya Life Science UK tracker

Sponsor

Medtronic Cardiac Ablation Solutions

Phase

Observational

Started

2021-04-22

Last updated

2026-05-27

Condition(s) studied

Arrhythmia

Investigational drug(s) / intervention(s)

DiamondTemp™ Ablation System

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

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Freedom from Recurrence at 12 Months — 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.
Freedom from Device / Procedure Related Adverse Events — 12 Months
Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months.

Trial sites (21)

Facility	City	Region
Sunshine Coast University Hospital	Birtinya	Australia
Fiona Stanley Hospital	Murdoch	Australia
Universitair Ziekenhuis Brussel	Jette	Belgium
CHRU de Tours - Hôpital Trousseau	Chambray-lès-Tours	France
Capio - Clinique du Tonkin	Villeurbanne	France
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum	Bad Oeynhausen	Germany
Universitäres Herzzentrum	Hamburg	Germany
Saint Vincenz Krankenhaus Paderborn	Paderborn	Germany
Humanitas Mater Domini	Castellanza	Italy
Ospedale di Conegliano - S. Maria dei Battuti	Conegliano	Italy
Ospedale dell'Angelo	Venezia	Italy
Catharina Ziekenhuis	Eindhoven	Netherlands
St. Antonius Ziekenhuis Nieuwegein	Nieuwegein	Netherlands
John Paul II Upper Silesian Medical Centre	Katowice	Poland
Hospital de Santa Marta	Lisbon	Portugal
University Medical Centre Ljubljana	Ljubljana	Slovenia
Hospital de la Santa Creu I Sant Pau	Barcelona	Spain
Hospital Universitario 12 de Octubre	Madrid	Spain
Inselspital - Universitätsspital Bern	Bern	Switzerland
Royal Sussex County Hospital	Brighton	United Kingdom
University Hospitals Coventry & Warwickshire	Coventry	United Kingdom

Other trials for the same condition

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04735016 on ClinicalTrials.gov ↗ ← All trials in the UK