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

Leadless Pacemaker Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Pacemaker; Cardiac Pacing, Artificial; Registries; Leadless Pacemaker

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Matthias Granner, MD; Phone Number: +432742900422632; Email: matthias.granner@stpoelten.lknoe.at
• Study Contact Backup: Name: Department of Internal Medicine III; Phone Number: +432742900412541; Email: interne3@stpolten.lknoe.at

Study Locations

• Austria
  • Lower Austria
    • Sankt Pölten, Lower Austria, Austria, 3100
      • Recruiting
      • University Hospital of St. Pölten
      • Contact: Department of Internal Medicine III; Phone Number: +432742900412541; Email: interne3@stpoelten.lknoe.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related complication rate (medium- and long-term)	Cumulative incidence of complications requiring medical or surgical intervention (e.g., device malfunction, infection, need for extraction, upgrade)	Up to 10 years after implantation
Ventricular pacing burden	Percentage of ventricular pacing and triggered pacing as recorded by device interrogation	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	Change in 12-Item Short Form Health Survey (SF-12) questionnaire score / The SF-12 questionnaire is a validated health-related quality of life instrument with two subscales: Physical Component Summary (PCS) and Mental Component Summary (MCS). Each subscale ranges from 0 to 100 points, where higher scores indicate better health-related quality of life.	1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device	Pacing thresholds (in Volts at 0.24 ms pulse width)	Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device	Sensing Amplitude (R-wave, in millivolts [mV])	Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device	Lead impedance (in Ohms [Ω])	Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device	Estimated battery longevity (in years)	Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Left ventricular ejection fraction on Echocardiography	in %	1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Left ventricular dimensions on Echocardiography	end-diastolic and end-systolic diameters, in mm	1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Right ventricular function on Echocardiography	Tricuspid Annular Plane Systolic Excursion (TAPSE) in mm	1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Collaborators and Investigators

• Sponsor: Karl Landsteiner University of Health Sciences
• Collaborators: University Hospital St. Polten
• Investigators: Principal Investigator: Julia Mascherbauer, MD, Professor, Department of Internal Medicine III, University Hospital of St. Pölten

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2015
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2035

Study Registration Dates

• First Submitted: September 16, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Registry; Pacemaker; Bradycardia; Cardiac Pacing; Leadless Pacemaker; Heart Conduction System Disease; Pacemaker Complication; Leadless Pacemaker Outcomes
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Bradycardia
• Other Study ID Numbers: GS3-EK-4/899-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No