DiamondTemp Global Registry

NCT ID: NCT04735016

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-22

Study Completion Date

2031-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment Arm

Patients enrolled and treated with the DiamondTemp™ Ablation System

DiamondTemp™ Ablation System

Intervention Type DEVICE

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

Interventions

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DiamondTemp™ Ablation System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sunshine Coast University Hospital

Birtinya, , Australia

Site Status ACTIVE_NOT_RECRUITING

Fiona Stanley Hospital

Murdoch, , Australia

Site Status RECRUITING

Universitair Ziekenhuis Brussel

Jette, , Belgium

Site Status ACTIVE_NOT_RECRUITING

CHRU de Tours - Hôpital Trousseau

Chambray-lès-Tours, , France

Site Status COMPLETED

Capio - Clinique du Tonkin

Villeurbanne, , France

Site Status COMPLETED

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Bad Oeynhausen, , Germany

Site Status COMPLETED

Universitäres Herzzentrum

Hamburg, , Germany

Site Status COMPLETED

Saint Vincenz Krankenhaus Paderborn

Paderborn, , Germany

Site Status COMPLETED

Humanitas Mater Domini

Castellanza, , Italy

Site Status ACTIVE_NOT_RECRUITING

Ospedale di Conegliano - S. Maria dei Battuti

Conegliano, , Italy

Site Status COMPLETED

Ospedale dell'Angelo

Venezia, , Italy

Site Status COMPLETED

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status COMPLETED

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, , Netherlands

Site Status COMPLETED

John Paul II Upper Silesian Medical Centre

Katowice, , Poland

Site Status ACTIVE_NOT_RECRUITING

Hospital de Santa Marta

Lisbon, , Portugal

Site Status RECRUITING

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status ACTIVE_NOT_RECRUITING

Hospital de la Santa Creu I Sant Pau

Barcelona, , Spain

Site Status COMPLETED

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status COMPLETED

Inselspital - Universitätsspital Bern

Bern, , Switzerland

Site Status COMPLETED

Royal Sussex County Hospital

Brighton, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

University Hospitals Coventry & Warwickshire

Coventry, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Countries

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Australia Belgium France Germany Italy Netherlands Poland Portugal Slovenia Spain Switzerland United Kingdom

Central Contacts

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Josman Suri

Role: CONTACT

7635050262

Facility Contacts

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Vincent Paul, MD

Role: primary

Mário João Martins Oliviera, MD

Role: primary

+351 213578632

Other Identifiers

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MDT20059

Identifier Type: -

Identifier Source: org_study_id

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