NCT07246135 Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
| NCT ID | NCT07246135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karl Landsteiner University of Health Sciences |
| Condition | Pacemaker |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2015-06-18 |
| Primary Completion | 2035-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2015-06-18 with a primary completion date of 2035-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Julia Mascherbauer, MD, Professor
PRINCIPAL INVESTIGATOR
Department of Internal Medicine III, University Hospital of St. Pölten
Frequently Asked Questions
Who can join the NCT07246135 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pacemaker. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07246135 currently recruiting?
Yes, NCT07246135 is actively recruiting participants. Contact the research team at matthias.granner@stpoelten.lknoe.at for enrollment information.
Where is the NCT07246135 trial being conducted?
This trial is being conducted at Sankt Pölten, Austria.
Who is sponsoring the NCT07246135 clinical trial?
NCT07246135 is sponsored by Karl Landsteiner University of Health Sciences. The principal investigator is Julia Mascherbauer, MD, Professor at Department of Internal Medicine III, University Hospital of St. Pölten. The trial plans to enroll 700 participants.