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Register för leadless pacemakrar: Resultat och uppföljning från sjukhuset i St. Pölten (LPR)

4 november 2026 uppdaterad av: Karl Landsteiner University of Health Sciences

Register för ledarlös 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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

700

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Österrike
    • Lower Austria
      • Sankt Pölten, Lower Austria, Österrike, 3100
        • Rekrytering
        • University Hospital of St. Pölten
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: OTHER

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Procedural success rate
Tidsram: Periprocedural / at Day 1

Successful implantation of a leadless pacemaker with acceptable electrical parameters and no need for conversion to a transvenous system
Periprocedural / at Day 1
Incidence of acute complications
Tidsram: Within 30 days after implantation

Rate of periprocedural complications (e.g., vascular complications, arrhythmias, pericardial effusion, device dislodgement)
Within 30 days after implantation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Allmän dödlighet
Tidsram: Under hela uppföljningen (upp till 10 år)
Under hela uppföljningen (upp till 10 år)
Inläggningar relaterade till hjärtarytmier eller hjärtsvikt
Tidsram: Under hela uppföljningsperioden (upp till 10 år)
Under hela uppföljningsperioden (upp till 10 år)
Device-related complication rate (medium- and long-term)
Tidsram: Up to 10 years after implantation

Cumulative incidence of complications requiring medical or surgical intervention (e.g., device malfunction, infection, need for extraction, upgrade)
Up to 10 years after implantation
Ventricular pacing burden
Tidsram: 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
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Quality of Life after Implantation
Tidsram: 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.
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device
Tidsram: 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)
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device
Tidsram: 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])
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device
Tidsram: 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])
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Electrical performance of the device
Tidsram: 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)
Day 1, 3 months post-implant (±2 weeks), 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Left ventricular ejection fraction on Echocardiography
Tidsram: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

in %
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Left ventricular dimensions on Echocardiography
Tidsram: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

end-diastolic and end-systolic diameters, in mm
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter
Right ventricular function on Echocardiography
Tidsram: 1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Tricuspid Annular Plane Systolic Excursion (TAPSE) in mm
1 year after Implantation (±2 weeks), every 12th month (±2 weeks) thereafter

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Karl Landsteiner University of Health Sciences

Samarbetspartners

University Hospital St. Polten

Utredare

  • Huvudutredare: Julia Mascherbauer, MD, Professor, Department of Internal Medicine III, University Hospital of St. Pölten

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 juni 2015

Primärt slutförande (Beräknad)

1 januari 2035

Avslutad studie (Beräknad)

1 januari 2035

Studieregistreringsdatum

Först inskickad

16 september 2025

Först inskickad som uppfyllde QC-kriterierna

17 november 2025

Första postat (Faktisk)

24 november 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GS3-EK-4/899-2024

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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