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.

Study Overview

• Status: Recruiting
• Conditions: Patent Ductus Arteriosus
• Intervention / Treatment: Device: HeartR™ PDA Occluder

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

Study Locations

• Indonesia
  • Riau
    • Pekanbaru, Riau, Indonesia, 28156
      • Recruiting
      • RS Awal Bros
      • Contact: Shirley Leonita Anggriawan, Dr. Sp.A (K); Phone Number: 0761-47333; Email: mkt.pku@awalbros.com
      • Principal Investigator: Shirley Leonita Anggriawan, Dr. Sp.A (K)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	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.; Complete closure of the defects, with no residual shunt confirmed by Doppler echocardiography at 12 months post-implantation.	12 months post-implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete closure of the defects with no residual shunt	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	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)	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)	Incidence of device or procedure related Serious Adverse Events (SAEs)	from attempted procedure to 24 months post-implantation
Incidence of death	Incidence of death	from attempted procedure to 24 months post-implantation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ductus Arteriosus, Patent
• Other Study ID Numbers: LT-TS-2-2025-01