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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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Riau
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Pekanbaru, Riau, Indonesia, 28156
- Rekruttering
- RS Awal Bros
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Ta kontakt med:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
- Telefonnummer: 0761-47333
- E-post: mkt.pku@awalbros.com
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Hovedetterforsker:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Procedural success
Tidsramme: 12 months post-implantation
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12 months post-implantation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Complete closure of the defects with no residual shunt
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LT-TS-2-2025-01
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