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Clinical Trials in Australia / NCT04735016
Active, not recruiting Observational

DiamondTemp Global Registry

NCT04735016 · tracked via the Priya Life Science Australia 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
No
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)

FacilityCityRegionStatus
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

More Medtronic Cardiac Ablation Solutions trials in Australia

Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF) Recruiting

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 Australia