PacemakerLPRNCT07246135
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
An observational study of Pacemaker and Leadless Pacemaker, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Leadless Pacemaker, Cardiac Pacing, Artificial
- How many people
- 700 participants
- Where
- 1 siteAustria
- Study dates
- 18 Jun 2015to Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
University Hospital of St. Pölten
Sankt Pölten, Lower Austria, 3100
Department of Internal Medicine III, +432742900412541, interne3@stpoelten.lknoe.at
About this study
Official title: 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.
- 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
- Medical subject headings
- Bradycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate
Successful implantation of a leadless pacemaker with acceptable electrical parameters and no need for conversion to a transvenous system
Measured: Periprocedural / at Day 1
Incidence of acute complications
Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)
Measured: Within 30 days after implantation
Secondary outcomes (12)
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)
Measured: Up to 10 years after implantation
Ventricular pacing burden
Percentage of ventricular pacing and triggered pacing as recorded by device interrogation
Measured: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
All-cause mortality
Measured: Throughout follow-up (up to 10 years)
Hospitalizations related to cardiac arrhythmias or heart failure
Measured: 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.
Measured: 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)
Measured: 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])
Measured: 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])
Measured: 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)
Measured: 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 %
Measured: 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
Measured: 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
Measured: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start18 Jun 2015
- Primary completionJan 2035 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital St. Polten
- Responsible party
- Sponsor
- Investigators
- Julia Mascherbauer, MD, Professor, Principal investigator, Department of Internal Medicine III, University Hospital of St. Pölten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246135
- Sponsor's protocol ID
- GS3-EK-4/899-2024
- Acronym
- LPR
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leadless Pacemaker Registry
- ClinicalTrials.gov ID
- NCT07246135
- Acronym / sponsor ID
- LPR / GS3-EK-4/899-2024
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Karl Landsteiner University of Health SciencesUniversity, hospital or other
- Collaborators
- University Hospital St. Polten
- Study start
- 18 Jun 2015 (actual)
- Primary completion
- Jan 2035 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Incidence of acute complications
Time frame: Within 30 days after implantation
Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)
12 secondary outcomes
Device-related complication rate (medium- and long-term)
Time frame: Up to 10 years after implantation
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
All-cause mortality
Time frame: Throughout follow-up (up to 10 years)
Hospitalizations related to cardiac arrhythmias or heart failure
Time frame: Throughout follow-up (up to 10 years)
Quality of Life after Implantation
Time frame: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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
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
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
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
Left ventricular ejection fraction on Echocardiography
Time frame: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Left ventricular dimensions on Echocardiography
Time frame: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Right ventricular function on Echocardiography
Time frame: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Mascherbauer, MD, Professor principal investigator
Department of Internal Medicine III, University Hospital of St. Pölten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker and Leadless Pacemaker, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Granner, MD (+432742900422632, matthias.granner@stpoelten.lknoe.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success rate (time frame: Periprocedural / at Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.