Patent Ductus Arteriosus
Conditions
Brief summary
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.
Interventions
DEVICEHeartR™ PDA Occluder
Lifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA).
Sponsors
Lifetech Scientific (Shenzhen) Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) and were implanted with the HeartR™ PDA Occluder as per IFU instructions 2. Age ≥ 6 months at the time of implantation. 3. Weighing ≥ 6 kg at the time of implantation. 4. Narrowest portion of the PDA ≥ 2mm at the time of implantation.
Exclusion criteria
Patients did not conduct any follow up visit after hospital discharge.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 12 months post-implantation | 1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention and procedure/device related death at 12 months post-implantation. 2. Complete closure of the defects, with no residual shunt confirmed by Doppler echocardiography at 12 months post-implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete closure of the defects with no residual shunt | before discharge and at 6 months post-implantation | Complete closure of the defects with no residual shunt |
| Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention | before discharge and at 6 months, 12 months post-implantation | Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention |
| Incidence of device or procedure related Adverse Events (AEs) | from attempted procedure to 24 months post-implantation | Incidence of device or procedure related Adverse Events (AEs) |
| Incidence of device or procedure related Serious Adverse Events (SAEs) | from attempted procedure to 24 months post-implantation | Incidence of device or procedure related Serious Adverse Events (SAEs) |
| Incidence of death | from attempted procedure to 24 months post-implantation | Incidence of death |
Countries
Indonesia
Outcome results
None listed