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

NCT07246135 | Recruiting

• 1 other identifier: GS3-EK-4/899-2024
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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

Keywords

Registry; Leadless Pacemaker; Pacemaker; Cardiac Pacing; Pacemaker Complication; Leadless Pacemaker Outcomes; Heart Conduction System Disease; Bradycardia

Outcome Measures

Primary Outcomes (2)

• Procedural success rate

  Successful implantation of a leadless pacemaker with acceptable electrical parameters and no need for conversion to a transvenous system

  Periprocedural / at Day 1

• Incidence of acute complications

  Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)

  Within 30 days after implantation

Secondary Outcomes (12)

• Device-related complication rate (medium- and long-term)

  Up to 10 years after implantation

• Ventricular pacing burden

  Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

• All-cause mortality

  Throughout follow-up (up to 10 years)

• Hospitalizations related to cardiac arrhythmias or heart failure

  Throughout follow-up (up to 10 years)

• Quality of Life after Implantation

  1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients undergoing implantation of a leadless pacemaker at University Hospital St. Pölten, as well as patients who previously received a leadless pacemaker at the same institution since June 2015. Both prospective and retrospective patients are included.

You may qualify if:

• Patients undergoing implantation of a leadless pacemaker at the University Hospital of St. Pölten
• 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.

Sponsors & Collaborators

• Karl Landsteiner University of Health Sciences: lead
• University Hospital St. Polten: collaborator

Study Sites (1)

University Hospital of St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia Mascherbauer, MD, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Granner, MD

CONTACT

+432742900422632; matthias.granner@stpoelten.lknoe.at

Department of Internal Medicine III

CONTACT

+432742900412541; interne3@stpolten.lknoe.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: November 24, 2025
• Study Start: June 18, 2015
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2035
• Last Updated: November 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)