NCT07646704 HeartR™ PDA Occluder Post-Market Follow-Up Study
| NCT ID | NCT07646704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. |
| Condition | Patent Ductus Arteriosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2025-04-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07646704 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, studying Patent Ductus Arteriosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07646704 currently recruiting?
Yes, NCT07646704 is actively recruiting participants. Visit ClinicalTrials.gov or contact Lifetech Scientific (Shenzhen) Co., Ltd. to inquire about joining.
Where is the NCT07646704 trial being conducted?
This trial is being conducted at Pekanbaru, Indonesia.
Who is sponsoring the NCT07646704 clinical trial?
NCT07646704 is sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. The trial plans to enroll 140 participants.