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 Type
OBSERVATIONAL
Enrollment
700
University Hospital of St. Pölten
Sankt Pölten, Lower Austria, Austria
RECRUITINGProcedural success rate
Successful implantation of a leadless pacemaker with acceptable electrical parameters and no need for conversion to a transvenous system
Time frame: Periprocedural / at Day 1
Incidence of acute complications
Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)
Time frame: Within 30 days after implantation
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)
Time frame: Up to 10 years after implantation
Ventricular pacing burden
Percentage of ventricular pacing and triggered pacing as recorded by device interrogation
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
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.
Time frame: 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)
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
Sensing Amplitude (R-wave, in millivolts \[mV\])
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
Lead impedance (in Ohms \[Ω\])
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
Estimated battery longevity (in years)
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
in %
Time frame: 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
Time frame: 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
Time frame: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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