Registry for patients undergoing cardiac electronic device procedures
European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
This study is collecting information from patients getting heart devices to see how safe and effective these procedures are over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kiel Academic / other |
| Locations | 8 sites (Wiener Neustadt and 7 other locations) |
| Trial ID | NCT04735666 on ClinicalTrials.gov |
What this trial studies
The European TauroPace Registry is a prospective observational study conducted by the University of Schleswig-Holstein, focusing on patients undergoing procedures related to cardiac implantable electronic devices (CIEDs). This multi-center study aims to collect data on safety and effectiveness over a period of up to 10 years, with evaluations at 3 and 12 months, and annual follow-ups for up to 3 years. The study will include at least 2300 procedures and will utilize a unique Case Report Form system to record patient data throughout the observation period.
Who should consider this trial
Good fit: Ideal candidates for this study are patients eligible for CIED-related surgical procedures who can safely use the TauroPace™ system.
Not a fit: Patients under 18 years old or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of safety and effectiveness of CIED procedures, potentially leading to improved patient outcomes.
How similar studies have performed: While observational studies on CIEDs exist, this specific registry approach focusing on TauroPace™ is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Use of TauroPace™ is indicated and not contra-indicated according to its current Instructions For Use (IFU) * Participant is eligible for a CIED related surgery procedure. Exclusion Criteria: * Age\<18years * Participant incapable of signing Patient Informed Consent (mentally or physically) or does not sign.
Where this trial is running
Wiener Neustadt and 7 other locations
- Landeskrankenhaus Wiener Neustadt — Wiener Neustadt, Austria (Not_yet_recruiting)
- Louis Pradel Hospital — Lyon, Bron, France (Not_yet_recruiting)
- Krankenhaus Landshut Achdorf — Landshut, Bavaria, Germany (Active_not_recruiting)
- Helios Klinik Cuxhaven — Cuxhaven, Niedersachsen, Germany (Recruiting)
- Helios Klinik Wesermarsch — Nordenham, Niedersachsen, Germany (Recruiting)
- University Hospital Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (Completed)
- Ospedale Regionale San Maurizio — Bolzano, Alto Adige, Italy (Not_yet_recruiting)
- Great Western Hospitals NHS Foundation Trust — Swindon, United Kingdom (Active_not_recruiting)
Study contacts
- Principal investigator: Hendrik Bonnemeier, PhD — University of Kiel - Medical Faculty
- Study coordinator: Clinician scientist, MD
- Email: sportmedic@gmail.com
- Phone: +11-49-17696450666
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.