DiamondTemp Global Registry

Recruiting

• Conditions: Arrhythmia
• Interventions: Device: DiamondTemp™ Ablation System

• Registration Number: NCT04735016
• Lead Sponsor: Medtronic Cardiac Ablation Solutions

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-02
• Study Start: 2021-04-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2031-03
• Study Completion: 2031-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Arm	DiamondTemp™ Ablation System	Patients enrolled and treated with the DiamondTemp™ Ablation System

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (21)

Hospital de la Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

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; 🇵🇹 Lisboa, Portugal

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia

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