DiamondTemp Global Registry

Arrhythmia Clinical Trial

Official title:

DiamondTemp Global Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735016
• Other study ID #: MDT20059
• Status: Recruiting
• Start date: April 22, 2021
• Est. completion date: March 2031

Study information

• Verified date: April 2024
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: Ryan Radtke
• Phone: 712.941.9372
• Email: ryan.s.radtke[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2031
• Est. primary completion date: March 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Recurrence at 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.	12 Months
Primary	Freedom from Device / Procedure Related Adverse Events	Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months.	12 Months