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NCT Number: NCT07246135

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

Location status: Recruiting

Location contact

Department of Internal Medicine III

CONTACT

[email protected]

+432742900412541

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Procedural success rate

    Time frame: Periprocedural / at Day 1

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

  2. Incidence of acute complications

    Time frame: Within 30 days after implantation

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

Secondary outcomes

  1. Device-related complication rate (medium- and long-term)

    Time frame: Up to 10 years after implantation

    Cumulative incidence of complications requiring medical or surgical intervention (e.g., device malfunction, infection, need for extraction, upgrade)

  2. Ventricular pacing burden

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

    Percentage of ventricular pacing and triggered pacing as recorded by device interrogation

  3. All-cause mortality

    Time frame: Throughout follow-up (up to 10 years)

  4. Hospitalizations related to cardiac arrhythmias or heart failure

    Time frame: Throughout follow-up (up to 10 years)

  5. Quality of Life after Implantation

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

    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.

  6. Electrical performance of the device

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

    Pacing thresholds (in Volts at 0.24 ms pulse width)

  7. Electrical performance of the device

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

    Sensing Amplitude (R-wave, in millivolts [mV])

  8. Electrical performance of the device

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

    Lead impedance (in Ohms [Ω])

  9. Electrical performance of the device

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

    Estimated battery longevity (in years)

  10. Left ventricular ejection fraction on Echocardiography

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

    in %

  11. Left ventricular dimensions on Echocardiography

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

    end-diastolic and end-systolic diameters, in mm

  12. Right ventricular function on Echocardiography

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

    Tricuspid Annular Plane Systolic Excursion (TAPSE) in mm

Study contacts

Contact information is provided by the study sponsor or research team.

Department of Internal Medicine III

CONTACT

[email protected]

+432742900412541

Matthias Granner, MD

CONTACT

[email protected]

+432742900422632

Sponsors and collaborators

Lead sponsor

Karl Landsteiner University of Health Sciences

Other

Collaborators

  • University Hospital St. Polten

Registry information

Official study title

Leadless Pacemaker Registry

Acronym: LPR

Important dates

Study start
2015
Primary completion
2035
Study completion
2035
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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