Registrer for lederløs pacemaker: Resultater og opfølgning fra St. Pöltens Universitetshospital (LPR)
Register for ledningsløs pacemaker
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Matthias Granner, MD
- Telefonnummer: +432742900422632
- E-mail: matthias.granner@stpoelten.lknoe.at
Undersøgelse Kontakt Backup
- Navn: Department of Internal Medicine III
- Telefonnummer: +432742900412541
- E-mail: interne3@stpolten.lknoe.at
Studiesteder
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Lower Austria
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Sankt Pölten, Lower Austria, Østrig, 3100
- Rekruttering
- University Hospital of St. Pölten
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Kontakt:
- Department of Internal Medicine III
- Telefonnummer: +432742900412541
- E-mail: interne3@stpoelten.lknoe.at
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: OTHER
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Procedural success rate
Tidsramme: Periprocedural / at Day 1
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Successful implantation of a leadless pacemaker with acceptable electrical parameters and no need for conversion to a transvenous system |
Periprocedural / at Day 1
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Incidence of acute complications
Tidsramme: Within 30 days after implantation
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Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement) |
Within 30 days after implantation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Dødelighed af alle årsager
Tidsramme: Igennem hele opfølgningsperioden (op til 10 år)
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Igennem hele opfølgningsperioden (op til 10 år)
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Indlæggelser relateret til hjertearytmier eller hjertesvigt
Tidsramme: Igennem hele opfølgningsperioden (op til 10 år)
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Igennem hele opfølgningsperioden (op til 10 år)
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Device-related complication rate (medium- and long-term)
Tidsramme: Up to 10 years after implantation
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Cumulative incidence of complications requiring medical or surgical intervention (e.g., device malfunction, infection, need for extraction, upgrade) |
Up to 10 years after implantation
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Ventricular pacing burden
Tidsramme: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Percentage of ventricular pacing and triggered pacing as recorded by device interrogation |
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Quality of Life after Implantation
Tidsramme: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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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. |
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Electrical performance of the device
Tidsramme: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Pacing thresholds (in Volts at 0.24 ms pulse width) |
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Electrical performance of the device
Tidsramme: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Sensing Amplitude (R-wave, in millivolts [mV]) |
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Electrical performance of the device
Tidsramme: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Lead impedance (in Ohms [Ω]) |
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Electrical performance of the device
Tidsramme: Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Estimated battery longevity (in years) |
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Left ventricular ejection fraction on Echocardiography
Tidsramme: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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in % |
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Left ventricular dimensions on Echocardiography
Tidsramme: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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end-diastolic and end-systolic diameters, in mm |
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Right ventricular function on Echocardiography
Tidsramme: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Tricuspid Annular Plane Systolic Excursion (TAPSE) in mm |
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Julia Mascherbauer, MD, Professor, Department of Internal Medicine III, University Hospital of St. Pölten
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GS3-EK-4/899-2024
Plan for individuelle deltagerdata (IPD)
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