Registre des stimulateurs cardiaques sans sonde : Résultats et suivi de l'hôpital universitaire de St. Pölten (LPR)
Registre de stimulateurs cardiaques sans sonde
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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Matthias Granner, MD
- Numéro de téléphone: +432742900422632
- E-mail: matthias.granner@stpoelten.lknoe.at
Sauvegarde des contacts de l'étude
- Nom: Department of Internal Medicine III
- Numéro de téléphone: +432742900412541
- E-mail: interne3@stpolten.lknoe.at
Lieux d'étude
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Lower Austria
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Sankt Pölten, Lower Austria, L'Autriche, 3100
- Recrutement
- University Hospital of St. Pölten
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Contact:
- Department of Internal Medicine III
- Numéro de téléphone: +432742900412541
- E-mail: interne3@stpoelten.lknoe.at
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: OTHER
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Procedural success rate
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mortalité toutes causes confondues
Délai: Tout au long du suivi (jusqu'à 10 ans)
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Tout au long du suivi (jusqu'à 10 ans)
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|
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Hospitalisations liées aux arythmies cardiaques ou à l'insuffisance cardiaque
Délai: Tout au long du suivi (jusqu'à 10 ans)
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Tout au long du suivi (jusqu'à 10 ans)
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Device-related complication rate (medium- and long-term)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Julia Mascherbauer, MD, Professor, Department of Internal Medicine III, University Hospital of St. Pölten
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GS3-EK-4/899-2024
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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