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| Name | Class |
|---|---|
| University Hospital St. Polten | OTHER |
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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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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthias Granner, MD | Contact | +432742900422632 | matthias.granner@stpoelten.lknoe.at | |
| Department of Internal Medicine III | Contact | +432742900412541 | interne3@stpolten.lknoe.at |
| Name | Affiliation | Role |
|---|---|---|
| Julia Mascherbauer, MD, Professor | Department of Internal Medicine III, University Hospital of St. Pölten | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of St. Pölten | Recruiting | Sankt Pölten | Lower Austria | 3100 | Austria |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |