HeartR™ PDA Occluder Post-Market Follow-Up Study
The HeartR™ PDA Occluder Post-Market Clinical Follow-up (PMCF) Study is a multi-center, retrospective, single-arm study sponsored by Lifetech Scientific (Shenzhen) Co., Ltd., aiming to evaluate the long-term safety and performance of the Lifetech HeartR™ PDA Occluder in real-world clinical practice in Indonesia. A total of 140 subjects diagnosed with Patent Ductus Arteriosus (PDA) and treated with the HeartR™ PDA Occluder according to the Instructions for Use (IFU) will be enrolled.
Eligible subjects include patients aged ≥6 months, weighing ≥6 kg, with a PDA narrowest diameter ≥2 mm at the time of implantation. Patients without any follow-up visit after hospital discharge will be excluded from the study.
The primary endpoint is procedural success at 12 months post-implantation, defined as the absence of major adverse events including stroke/TIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention, and procedure/device-related death, together with complete defect closure confirmed by Doppler echocardiography without residual shunt.
Secondary endpoints include complete closure rates before discharge and at 6 months post-implantation, incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention, incidence of device- or procedure-related adverse events (AEs) and serious adverse events (SAEs), as well as all-cause mortality through 24 months post-implantation.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Riau
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Pekanbaru, Riau, Indonésie, 28156
- Recrutement
- RS Awal Bros
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Contact:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
- Numéro de téléphone: 0761-47333
- E-mail: mkt.pku@awalbros.com
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Chercheur principal:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) and were implanted with the HeartR™ PDA Occluder as per IFU instructions
- Age ≥ 6 months at the time of implantation.
- Weighing ≥ 6 kg at the time of implantation.
- Narrowest portion of the PDA ≥ 2mm at the time of implantation.
Exclusion Criteria:
Patients did not conduct any follow up visit after hospital discharge.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Procedural success
Délai: 12 months post-implantation
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12 months post-implantation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Complete closure of the defects with no residual shunt
Délai: before discharge and at 6 months post-implantation
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Complete closure of the defects with no residual shunt
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before discharge and at 6 months post-implantation
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Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
Délai: before discharge and at 6 months, 12 months post-implantation
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Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
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before discharge and at 6 months, 12 months post-implantation
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Incidence of device or procedure related Adverse Events (AEs)
Délai: from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Adverse Events (AEs)
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from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Serious Adverse Events (SAEs)
Délai: from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Serious Adverse Events (SAEs)
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from attempted procedure to 24 months post-implantation
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Incidence of death
Délai: from attempted procedure to 24 months post-implantation
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Incidence of death
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from attempted procedure to 24 months post-implantation
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Collaborateurs et enquêteurs
Parrainer
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LT-TS-2-2025-01
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