Registry for patients treated with DiamondTemp Ablation System for arrhythmia
DiamondTemp Global Registry
This study is tracking how well the DiamondTemp Ablation System works and keeps patients safe after treating their arrhythmia over the course of a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Cardiac Ablation Solutions Industry-sponsored |
| Locations | 21 sites (Birtinya and 20 other locations) |
| Trial ID | NCT04735016 on ClinicalTrials.gov |
What this trial studies
The DiamondTemp Global Registry is a prospective, multi-center, observational registry that aims to collect clinical performance and safety data from patients treated with the DiamondTemp Ablation System for arrhythmia. This registry will follow patients for a minimum of 12 months post-procedure, documenting outcomes according to standard care practices at participating institutions. By gathering data from a broad patient population, the registry seeks to enhance understanding of the device's effectiveness and safety in real-world settings.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older who are scheduled to undergo a procedure using the DiamondTemp Ablation System.
Not a fit: Patients who are enrolled in concurrent studies that do not allow for participation in this registry may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of the DiamondTemp Ablation System, potentially improving treatment options for patients with arrhythmia.
How similar studies have performed: Other observational registries for cardiac ablation devices have shown success in providing important safety and efficacy data, suggesting that this approach is both valid and beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birtinya and 20 other locations
- Sunshine Coast University Hospital — Birtinya, Australia (Active_not_recruiting)
- Fiona Stanley Hospital — Murdoch, Australia (Active_not_recruiting)
- Universitair Ziekenhuis Brussel — Jette, Belgium (Completed)
- CHRU de Tours - Hôpital Trousseau — Chambray-lès-Tours, France (Completed)
- Capio - Clinique du Tonkin — Villeurbanne, France (Completed)
- Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum — Bad Oeynhausen, Germany (Completed)
- Universitäres Herzzentrum — Hamburg, Germany (Completed)
- Saint Vincenz Krankenhaus Paderborn — Paderborn, Germany (Completed)
- Humanitas Mater Domini — Castellanza, Italy (Active_not_recruiting)
- Ospedale di Conegliano - S. Maria dei Battuti — Conegliano, Italy (Completed)
- Ospedale dell'Angelo — Venezia, Italy (Completed)
- Catharina Ziekenhuis — Eindhoven, Netherlands (Completed)
- St. Antonius Ziekenhuis Nieuwegein — Nieuwegein, Netherlands (Completed)
- John Paul II Upper Silesian Medical Centre — Katowice, Poland (Completed)
- Hospital de Santa Marta — Lisbon, Portugal (Recruiting)
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Completed)
- Hospital de la Santa Creu I Sant Pau — Barcelona, Spain (Completed)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Completed)
- Inselspital - Universitätsspital Bern — Bern, Switzerland (Completed)
- Royal Sussex County Hospital — Brighton, United Kingdom (Completed)
- University Hospitals Coventry & Warwickshire — Coventry, United Kingdom (Completed)
Study contacts
- Study coordinator: Josman Suri
- Email: josman.suri@medtronic.com
- Phone: 7635050262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.