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HeartR™ PDA Occluder Post-Market Follow-Up Study

NCT07646704 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2026-06-15

No results posted yet for this study

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.

Conditions

  • Patent Ductus Arteriosus

Interventions

DEVICE

HeartR™ PDA Occluder

Lifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA).

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07646704 on ClinicalTrials.gov