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

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT07246135

Run by

Karl Landsteiner University of Health Sciences

People needed

700

Starts

2015-06-18

Expected to finish

2035-01-01

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• University Hospital of St. Pölten — Sankt Pölten, Lower Austria, Austria (enrolling)

Full record on ClinicalTrials.gov

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