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Recruiting NCT04735016

DiamondTemp Global Registry

Conditions: Arrhythmia

Sponsor: Medtronic Cardiac Ablation Solutions

trial.available_in: БГ
Overview
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.
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.
Who can participate
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
Locations 11
Australia (1)
Sunshine Coast University Hospital
Birtinya
ACTIVE_NOT_RECRUITING
Belgium (1)
Universitair Ziekenhuis Brussel
Jette
COMPLETED
France (1)
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours
COMPLETED
Germany (1)
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Bad Oeynhausen
COMPLETED
Italy (1)
Humanitas Mater Domini
Castellanza
ACTIVE_NOT_RECRUITING
Netherlands (1)
Catharina Ziekenhuis
Eindhoven
COMPLETED
Poland (1)
John Paul II Upper Silesian Medical Centre
Katowice
COMPLETED
Slovenia (1)
University Medical Centre Ljubljana
Ljubljana
COMPLETED
Spain (1)
Hospital de la Santa Creu I Sant Pau
Barcelona
COMPLETED
Switzerland (1)
Inselspital - Universitätsspital Bern
Bern
COMPLETED
United Kingdom (1)
Royal Sussex County Hospital
Brighton
COMPLETED
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.04.2021
Completion date
01.03.2031
Registry ID
NCT04735016
Source
anzctr
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