HeartR™ PDA Occluder Post-Market Follow-Up Study

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.

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.