HeartR™ PDA Occluder Post-Market Follow-Up Study
ConditionPatent Ductus Arteriosus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
HeartR™ PDA Occluder
DeviceLifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA).
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
12 months post-implantationSecondary outcomes
1
Complete closure of the defects with no residual shunt
Complete closure of the defects with no residual shunt
Time frame
before discharge and at 6 months post-implantation2
Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
Time frame
before discharge and at 6 months, 12 months post-implantation3
Incidence of device or procedure related Adverse Events (AEs)
Incidence of device or procedure related Adverse Events (AEs)
Time frame
from attempted procedure to 24 months post-implantation4
Incidence of device or procedure related Serious Adverse Events (SAEs)
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time frame
from attempted procedure to 24 months post-implantationSponsors and contacts
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Source ClinicalTrials.gov