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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
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Riau
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Pekanbaru, Riau, Indonesien, 28156
- Rekrytering
- RS Awal Bros
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Kontakt:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
- Telefonnummer: 0761-47333
- E-post: mkt.pku@awalbros.com
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Huvudutredare:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Procedural success
Tidsram: 12 months post-implantation
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|
12 months post-implantation
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Complete closure of the defects with no residual shunt
Tidsram: before discharge and at 6 months post-implantation
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Complete closure of the defects with no residual shunt
|
before discharge and at 6 months post-implantation
|
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Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
Tidsram: 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
|
before discharge and at 6 months, 12 months post-implantation
|
|
Incidence of device or procedure related Adverse Events (AEs)
Tidsram: 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
|
|
Incidence of device or procedure related Serious Adverse Events (SAEs)
Tidsram: from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Serious Adverse Events (SAEs)
|
from attempted procedure to 24 months post-implantation
|
|
Incidence of death
Tidsram: 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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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LT-TS-2-2025-01
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