Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pacemaker, Leadless Pacemaker, Cardiac Pacing, Artificial, Registries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Leadless Pacemaker Registry
Overview
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.
Primary outcome measures
- Procedural success rate [Time frame: Periprocedural / at Day 1]
- Incidence of acute complications [Time frame: Within 30 days after implantation]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- University Hospital of St. Pölten — Sankt Pölten
Identifiers
NCT: NCT07246135 · GS3-EK-4/899-2024