Patent Ductus ArteriosusNCT07646704
HeartR™ PDA Occluder Post-Market Follow-Up Study
An observational study of Patent Ductus Arteriosus, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- HeartR™ PDA Occluder
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Apr 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients did not conduct any follow up visit after hospital discharge.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
RS Awal Bros
Pekanbaru, Riau, 28156
Shirley Leonita Anggriawan, Dr. Sp.A (K), 0761-47333, mkt.pku@awalbros.com
Shirley Leonita Anggriawan, Dr. Sp.A (K)
About this 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.
Read more
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
- Being tested
- HeartR™ PDA Occluder
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartR™ PDA OccluderDevice
Lifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-implantation
Secondary outcomes (5)
Complete closure of the defects with no residual shunt
Complete closure of the defects with no residual shunt
Measured: 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
Measured: 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)
Measured: 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)
Measured: from attempted procedure to 24 months post-implantation
Incidence of death
Incidence of death
Measured: from attempted procedure to 24 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start30 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646704
- Sponsor's protocol ID
- LT-TS-2-2025-01
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartR™ PDA Occluder Post-Market Follow-Up Study
- ClinicalTrials.gov ID
- NCT07646704
- Acronym / sponsor ID
- LT-TS-2-2025-01
- Conditions
- Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients did not conduct any follow up visit after hospital discharge.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartR™ PDA OccluderLifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA). | Device | – |
Primary outcome
Procedural success
Time frame: 12 months post-implantation
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.
5 secondary outcomes
Complete closure of the defects with no residual shunt
Time frame: before discharge and at 6 months post-implantation
Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
Time frame: before discharge and at 6 months, 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Time frame: from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time frame: from attempted procedure to 24 months post-implantation
Incidence of death
Time frame: from attempted procedure to 24 months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: 12 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.