Registro Pacemaker Senza Elettrocatetere: Risultati e Follow-up Dall'Ospedale Universitario di St. Pölten (LPR)
Registro del Pacemaker Senza Cavi
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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Matthias Granner, MD
- Numero di telefono: +432742900422632
- Email: matthias.granner@stpoelten.lknoe.at
Backup dei contatti dello studio
- Nome: Department of Internal Medicine III
- Numero di telefono: +432742900412541
- Email: interne3@stpolten.lknoe.at
Luoghi di studio
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Lower Austria
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Sankt Pölten, Lower Austria, Austria, 3100
- Reclutamento
- University Hospital of St. Pölten
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Contatto:
- Department of Internal Medicine III
- Numero di telefono: +432742900412541
- Email: interne3@stpoelten.lknoe.at
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: OTHER
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Procedural success rate
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mortalità per tutte le cause
Lasso di tempo: Durante il follow-up (fino a 10 anni)
|
Durante il follow-up (fino a 10 anni)
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|
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Ricoveri correlati ad aritmie cardiache o insufficienza cardiaca
Lasso di tempo: Durante il follow-up (fino a 10 anni)
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Durante il follow-up (fino a 10 anni)
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|
|
Device-related complication rate (medium- and long-term)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Electrical performance of the device
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Julia Mascherbauer, MD, Professor, Department of Internal Medicine III, University Hospital of St. Pölten
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GS3-EK-4/899-2024
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