Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorFirst Affiliated Hospital of Guangxi Medical University
About this trial
This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥1 year and weight ≥10 kg
Outlet VSD without ventricular malalignment
Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography
Written informed consent
Disqualifiers
Outlet VSD with a fibrous postero-inferior rim
Concurrent cardiac conditions requiring surgical correction
Severe pulmonary hypertension (PVR > 5 WU, assessed by right heart catheterization )
Intracardiac thrombus
Trial population
All consecutive patients diagnosed with outlet ventricular septal defects who undergo transcatheter closure with bioabsorbable occluders
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
transcatheter closure of outlet VSDs with bioabsorbable occluders
DeviceTranscatheter closure of outlet ventricular septal defects using a bioabsorbable occluder (Shape Memory Alloy Ltd, Shanghai, China). Implantation is performed via femoral/transthoracic approach under echocardiographic guidance following standard interventional protocols.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: BioOccl-VSD1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with procedural success
1. Occluder in correct anatomical position 2. Absence of major adverse events (all-cause mortality, all stroke, myocardial infarction, or re-hospitalization for device/procedure-related causes) 3) Residual shunt ≤ 2 mm and aortic regurgitation ≤ trace evaluated by transthoracic or transesophageal echocardiography
Time frame
12 monthsSecondary outcomes
1
Number of participants with technical success
Absence of mortality, correct positioning of the occluder into the proper anatomical location， aortic regurgitation≤ trace by transthoracic or transesophageal echocardiography
Time frame
Intraprocedural2
Number of participants with major adverse events
All-cause mortality, all stroke, myocardial infarction, re-hospitalization for device or procedure-related causes
Time frame
12/24/60 months3
Closure Efficacy
1）Successful closure: Rate of successful VSD closure (residual shunt ≤2 mm) assessed by transthoracic or transesophageal echocardiography. 2\) Complete closure: Rate of complete closure (no residual shunt) assessed by transthoracic or transesophageal echocardiography.
Time frame
Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months4
Aortic regurgitation severity
Aortic regurgitation severity measured by transthoracic and/or transesophageal echocardiography. Assessment of aortic regurgitation severity according to current recommendations for valvular heart disease.
Time frame
Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 monthsSponsors and contacts
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Source ClinicalTrials.gov
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