Actively Recruiting
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Led by Karl Landsteiner University of Health Sciences · Updated on 2025-11-24
700
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karl Landsteiner University of Health Sciences
Lead Sponsor
U
University Hospital St. Polten
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting and analyzing data on patients who receive leadless pacemakers at the University Hospital St. Pölten. This registry includes both new patients undergoing implantation and those who received a device since January 2021. The study aims to gather information on patient demographics, reasons for implantation, procedural details, and any complications that occur during follow-up, especially focusing on newer atrial mechanical sensing markers where long-term experience is limited. This is a combined prospective and retrospective registry enrolling all patients with leadless pacing devices. Data will be collected at implantation and continuously during follow-up visits throughout the entire study period. Follow-up data may be gathered in person or remotely. The study does not influence the medical treatment patients receive and includes long-term tracking of device performance, complications, and patient outcomes. Participants will be monitored regularly for procedural success, acute and long-term complications, device electrical performance, and heart function using echocardiography. Data on ventricular pacing burden, hospitalizations related to heart conditions, quality of life, and mortality will be collected up to 10 years after implantation. Both in-person visits and remote monitoring will be used to gather comprehensive information during this extended follow-up period.
CONDITIONS
Brief Title
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age 18 years or older
- Written informed consent provided by the patient
You will not qualify if you...
- Patients who decline or are unable to provide informed consent
- Patients in whom a conventional transvenous pacemaker is implanted
- Any condition that, in the opinion of the treating physician, precludes participation in the registry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years after implantation
Participants who have received a leadless pacemaker are observed for device performance, complications, and health outcomes over time.
Visits at Day 1, 3 months, 1 year, and annually thereafter
Trial Site Locations
Total: 1 location
1
University Hospital of St. Pölten
Sankt Pölten, Lower Austria, Austria, 3100
Actively Recruiting
Research Team
M
Matthias Granner, MD
D
Department of Internal Medicine III
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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