Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten

NCT ID: NCT07246135

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-18
• Study Completion Date: 2035-01-31

Brief Summary

The registry for leadless pacemakers will collect and annually analyze the data of all leadless pacemaker implantations at the University Hospital St. Pölten, including demographic information, indications, procedural details, acute, medium- and long-term complications during follow-up. Due to the partially novel nature of the signals (atrial mechanical sensing markers) and the lack of long-term experience to date, data on these aspects will also be collected and analyzed.

This is a single-center, prospective and retrospective registry that includes all patients receiving a leadless pacing device, as well as all patients who received a leadless pacing device between January 2021 and the start of the registry. All patients undergoing implantation of a leadless pacemaker will be invited to participate in the registry. For patients to be included retrospectively, participation in the registry will be offered at the time of their next routine follow-up visit.

The indication for leadless pacing will be determined by the physician responsible for the patient. Enrollment in the registry will in no case alter or influence the treatment the patient receives. Data collection will take place at the time of implantation and continuously during follow-up over the entire study period. Pacemaker-related data may be obtained either in person or via remote monitoring.

Conditions

Pacemaker; Leadless Pacemaker; Cardiac Pacing, Artificial; Registries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital St. Polten

OTHER

Sponsor Role: collaborator

Karl Landsteiner University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Mascherbauer, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine III, University Hospital of St. Pölten

Locations

University Hospital of St. Pölten

Sankt Pölten, Lower Austria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Matthias Granner, MD

Role: CONTACT

matthias.granner@stpoelten.lknoe.at

+432742900422632

Department of Internal Medicine III

Role: CONTACT

interne3@stpolten.lknoe.at

+432742900412541

Facility Contacts

Department of Internal Medicine III

Role: primary

interne3@stpoelten.lknoe.at

+432742900412541

Other Identifiers

GS3-EK-4/899-2024

Identifier Type: -

Identifier Source: org_study_id