Leadless pacemaker outcomes and follow-up at University Hospital St. Pölten
Leadless Pacemaker Registry
Karl Landsteiner University of Health Sciences · NCT07246135
This registry will collect and analyze outcomes and complications in adults who receive leadless pacemakers at University Hospital St. Pölten to see how the devices perform over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karl Landsteiner University of Health Sciences (other) |
| Locations | 1 site (Sankt Pölten, Lower Austria) |
| Trial ID | NCT07246135 on ClinicalTrials.gov |
What this trial studies
This single-center registry prospectively and retrospectively collects data on all leadless pacemaker implantations performed at University Hospital St. Pölten, including demographic information, implantation indications, procedural details, and follow-up findings. Data from patients implanted since 2015 (retrospective inclusion) and from new implantations (prospective inclusion) will be captured, and patients will be invited to participate at routine clinic visits. The registry will record acute, medium-, and long-term complications and will include analysis of novel atrial mechanical sensing markers for which long-term experience is limited. No investigational interventions are performed as part of the registry; it is observational and based on routine clinical care and follow-up visits.
Who should consider this trial
Good fit: Adults (age ≥18) who receive or previously received a leadless pacemaker at University Hospital St. Pölten and can provide written informed consent are eligible.
Not a fit: Patients with conventional transvenous pacemakers, those treated outside University Hospital St. Pölten, or individuals unable or unwilling to give informed consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could clarify safety, complication rates, and long-term performance of leadless pacemakers and help clinicians optimize device selection and follow-up care.
How similar studies have performed: Previous registries and device studies have shown generally favorable short- and mid-term safety and performance of leadless pacemakers, but aspects like atrial mechanical sensing remain relatively novel and lack long-term data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing implantation of a leadless pacemaker at the University Hospital of St. Pölten * Patients who previously received a leadless pacemaker between June 2015 and the start of the registry (retrospective inclusion). * Age ≥ 18 years. * Written informed consent provided by the patient. Exclusion Criteria: * Patients who decline or are unable to provide informed consent. * Patients in whom a conventional transvenous pacemaker is implanted (i.e., not leadless). * Any condition that, in the opinion of the treating physician, precludes participation in the registry.
Where this trial is running
Sankt Pölten, Lower Austria
- University Hospital of St. Pölten — Sankt Pölten, Lower Austria, Austria (RECRUITING)
Study contacts
- Principal investigator: Julia Mascherbauer, MD, Professor — Department of Internal Medicine III, University Hospital of St. Pölten
- Study coordinator: Matthias Granner, MD
- Email: matthias.granner@stpoelten.lknoe.at
- Phone: +432742900422632
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.
Conditions: Pacemaker, Leadless Pacemaker, Cardiac Pacing, Artificial, Registries, Registry, Cardiac Pacing, Pacemaker Complication, Leadless Pacemaker Outcomes