Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarl Landsteiner University of Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Procedural 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 12
Incidence of acute complications
Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)
Time frame
Within 30 days after implantationSecondary outcomes
1
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 implantation2
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) thereafter3
All-cause mortality
Time frame
Throughout follow-up (up to 10 years)4
Hospitalizations related to cardiac arrhythmias or heart failure
Time frame
Throughout follow-up (up to 10 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karl Landsteiner University of Health Sciences
Lead sponsor
University Hospital St. Polten
Collaborator
Source ClinicalTrials.gov