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

Karl Landsteiner University of Health Sciences

Status: Enrolling

Conditions: Cardiac Pacing, Artificial; Leadless Pacemaker; Pacemaker; Registries

Study type: Observational

Funder types: Other

Identifiers

NCT07246135

GS3-EK-4/899-2024

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.