University Hospital of St. Pölten
Sankt Pölten, Lower Austria, 3100, Austria
Location status: Recruiting
NCT Number: NCT07246135
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Sankt Pölten, Lower Austria, 3100, Austria
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Within 30 days after implantation
Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)
Time frame: Up to 10 years after implantation
Cumulative incidence of complications requiring medical or surgical intervention (e.g., device malfunction, infection, need for extraction, upgrade)
Time frame: 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
Time frame: Throughout follow-up (up to 10 years)
Time frame: Throughout follow-up (up to 10 years)
Time frame: 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.
Time frame: 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)
Time frame: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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
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
Estimated battery longevity (in years)
Time frame: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
in %
Time frame: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
end-diastolic and end-systolic diameters, in mm
Time frame: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Tricuspid Annular Plane Systolic Excursion (TAPSE) in mm
Contact information is provided by the study sponsor or research team.
Department of Internal Medicine III
CONTACT
Matthias Granner, MD
CONTACT
Karl Landsteiner University of Health Sciences
Other
Leadless Pacemaker Registry
Acronym: LPR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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