HeartR™ PDA Occluder Post-Market Follow-Up Study

NCT07646704 | Recruiting

• 1 other identifier: LT-TS-2-2025-01
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

• Procedural success

  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.

  12 months post-implantation

Secondary Outcomes (5)

• Complete closure of the defects with no residual shunt

  before discharge and at 6 months post-implantation

• 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)

  from attempted procedure to 24 months post-implantation

• Incidence of device or procedure related Serious Adverse Events (SAEs)

  from attempted procedure to 24 months post-implantation

• Incidence of death

  from attempted procedure to 24 months post-implantation

Interventions

HeartR™ PDA Occluder DEVICE

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

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) who underwent transcatheter closure using the Lifetech HeartR™ PDA Occluder in accordance with the Instructions for Use (IFU) in routine clinical practice in Indonesia. Eligible subjects were aged 6 months or older, weighed at least 6 kg, and had a PDA with a narrowest diameter of at least 2 mm at the time of implantation. Only patients with available post-discharge follow-up data will be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• Patients did not conduct any follow up visit after hospital discharge.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

RS Awal Bros

Pekanbaru, Riau, 28156, Indonesia

RECRUITING

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

ID (1)