Clinical trial NCT04735016: DiamondTemp Global Registry
Official title: DiamondTemp Global Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmia
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2021-02-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for an ablation with the DiamondTemp™ Ablation System may be approached regarding enrollment in this study.

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.

Eligibility criteria: 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 outcomes:
measure: Freedom from Recurrence at 12 Months
timeFrame: 12 Months
measure: Freedom from Device / Procedure Related Adverse Events
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Chambray-lès-Tours
country: France
facility: CHRU de Tours - Hôpital Trousseau
city: Villeurbanne
country: France
facility: Capio - Clinique du Tonkin
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum
city: Paderborn
country: Germany
facility: Saint Vincenz Krankenhaus Paderborn
city: Castellanza
country: Italy
facility: Humanitas Mater Domini
city: Conegliano
country: Italy
facility: Ospedale di Conegliano - S. Maria dei Battuti
city: Venezia
country: Italy
facility: Ospedale dell'Angelo
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Katowice
country: Poland
facility: John Paul II Upper Silesian Medical Centre
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire
Study officials:
References: