Cardiac Pacing, Artificial, Leadless Pacemaker, Pacemaker, Registries
Conditions
Keywords
Registry, Leadless Pacemaker, Pacemaker, Cardiac Pacing, Pacemaker Complication, Leadless Pacemaker Outcomes, Heart Conduction System Disease, Bradycardia
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.
Interventions
None listed
Sponsors
University Hospital St. Polten
Karl Landsteiner University of Health Sciences
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success rate | 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 | Within 30 days after implantation | Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Device-related complication rate (medium- and long-term) | Up to 10 years after implantation | Cumulative incidence of complications requiring medical or surgical intervention (e.g., device malfunction, infection, need for extraction, upgrade) |
| Left ventricular ejection fraction on Echocardiography | 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter | in % |
| Left ventricular dimensions on Echocardiography | 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter | end-diastolic and end-systolic diameters, in mm |
| Right ventricular function on Echocardiography | 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter | Tricuspid Annular Plane Systolic Excursion (TAPSE) in mm |
| Electrical performance of the device | 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) |
| Ventricular pacing burden | 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 |
Countries
Austria
Contacts
Primary ContactMatthias Granner, MD
Backup ContactDepartment of Internal Medicine III
Outcome results
None listed