Atrial Septal DefectNCT05371366
The Puncturable Atrial Septal Defect Occluder Trial (the PASSER Trial)
A study testing ASD closure with the novel occluder (ReAces) and ASD closure with normal occluder in people with Atrial Septal Defect, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- ASD closure with the novel occluder (ReAces) and ASD closure with normal occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2022to 22 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-70 years;
- with congenital secundum atrial septal defect;
- the maximal ASD diameter was ≤38 mm;
- with atrial-level left-to-right shunt, with Qp/Qs shunt ratio ≥1.5:1, or TTE or clinical manifestations indicated the existence of defect that inducing overfilling of right atrium;
- the distance from the margin of defect to coronary sinus, atrioventricular (AV) valve, and right superior pulmonary vein (RSPV) was ≥5 mm, according to the echocardiography measurements;
- volunteered to participate in this study, and signed informed consents.
Who cannot join
- ostium primordium ASD and sinus venosus ASD.
- infective endocarditis and hemorrhagic disorders.
- active thrombosis.
- patients with severe pulmonary hypertension (mean pulmonary artery pressure measured by catheter > 30 mmHg) who are not taking targeted drugs
- patients with a porous atrial septal defect that cannot be completely occluded by a single occluder.
- with severe myocardial disorders or valvular disease not associated with ASD
Show all 19Show fewer
- infectious disease within the last 1 month, or uncontrolled infectious disease
- bleeding disorders, untreated gastric or duodenal ulcers
- thrombosis in left atrium
- partial or total pulmonary vein ectopic drainage
- left atrial septum, left atrial or left ventricular dysplasia
- Patients whose size (too small for TEE probe, catheter size, etc.) or physical condition (active infection, etc.) makes them unsuitable for cardiac catheterization
- Patients who are allergic to nickel
- Patients with any contraindication to aspirin therapy (except for those able to take other antiplatelet agents for 6 consecutive months).
- Pregnant or lactating women and those who plan to become pregnant during the trial
- Patients with a life expectancy of <12 months or those who are unable to complete the study's prescribed follow-up schedule
- Participation in another clinical trial of a drug or medical device within 30 days prior to screening.
- Patients who have previously undergone surgical atrial septal defect repair or percutaneous interventional atrial septal defect closure.
- Patients who, in the opinion of the investigator, are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Wenzhi Pan, Dr, +86 13774475922, peden@sina.com
Junbo Ge, Dr, +86 13901977506, ge.junbo@zs-hospital.sh.cn
About this study
Official title: A Multicenter, Randomized, Parallel-controlled Clinical Trial to Evaluate the Efficacy and Safety of a New Atrial Septal Defect Occluder, ReAces®, and Delivery System for the Treatment of Atrial Septal Defect Occlusion
A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion. Compared with the traditional atrial septal occluder, this new atrial septal occluder supports re-puncture after occluder implantation. Thus those patients who have undergone atrial septal defect closure with the novel device may be eligible for future radiofrequency ablation of atrial fibrillation or mitral valve intervention.
The trial is expected to enroll 128 patients who will be randomly assigned to the test group or control group in a 1:1 ratio. Patients in test group will received ReAces occluder，and the others the regular occluder.The experiment is scheduled to enroll 128 patients who will be randomly allocated to one of two groups: test or control. Patients in the test group will receive a ReAces occluder, while those in the control group will receive a standard occluder.The safety and efficacy of the two groups at 1 year after surgery will be compared.
- Conditions
- Atrial Septal Defect
- Being tested
- ASD closure with the novel occluder (ReAces), ASD closure with normal occluder
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASD closure with the novel occluder (ReAces)Device
Transcatheter closure atrial septal defect with the novel occluder (ReAces)
ASD closure with normal occluderDevice
Transcatheter closure atrial septal defect with normal occluder
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients with ASD assigned to experimental group will receive the novel ASD occluder (ReAces) Receives: Device: ASD closure with the novel occluder (ReAces) |
| Control Group | Active comparator | Patients with ASD assigned to control group will receive the normal occluder Receives: Device: ASD closure with normal occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful rate of complete closure of atrial septal defect
The success rate of complete closure at 12 months after the procedure was used as the main efficacy index to evaluate the effectiveness of the novel atrial septal defect occluder ReAces, reflecting the long-term implantation effect of the device.
Measured: 0-360 days
Secondary outcomes (1)
Adverse events
all cause and cardiovascular mortality, pericardial tamponade, cerebrovascular events, malignant arrhythmia, infection, device migration, and occluder-related thrombosis or embolization during the operation or follow up.
Measured: 0-360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start22 Apr 2022
- Primary completion22 Apr 2023 (estimated)
- Study completion22 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371366
- Sponsor's protocol ID
- HYYL2022-06ZC-01
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fang Y, Li M, Zhang Z, Zhang C, Fang Z, Zhang D, Liu H, Pan W, Zhou D, Ge J. Comparison of a Novel Occluder Versus Traditional Occluder in Atrial Septal Defect: A Randomized Trial. J Am Heart Assoc. 2026 Sep 18:e045052. doi: 10.1161/JAHA.125.045052. Online ahead of print.
PubMed 42757893Fang Y, Hou K, Lin D, Zhou D, Pan W, Ge J. Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders. BMC Cardiovasc Disord. 2024 Dec 30;24(1):755. doi: 10.1186/s12872-024-04438-1.
PubMed 39734195
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-controlled Clinical Trial to Evaluate the Efficacy and Safety of a New Atrial Septal Defect Occluder, ReAces®, and Delivery System for the Treatment of Atrial Septal Defect Occlusion
- ClinicalTrials.gov ID
- NCT05371366
- Acronym / sponsor ID
- HYYL2022-06ZC-01
- Conditions
- Atrial Septal Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 22 Apr 2023 (estimated)
- Study completion
- 22 Apr 2023 (estimated)
- First posted
- 12 May 2022 (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.
A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion. Compared with the traditional atrial septal occluder, this new atrial septal occluder supports re-puncture after occluder implantation. Thus those patients who have undergone atrial septal defect closure with the novel device may be eligible for future radiofrequency ablation of atrial fibrillation or mitral valve intervention.
The trial is expected to enroll 128 patients who will be randomly assigned to the test group or control group in a 1:1 ratio. Patients in test group will received ReAces occluder，and the others the regular occluder.The experiment is scheduled to enroll 128 patients who will be randomly allocated to one of two groups: test or control. Patients in the test group will receive a ReAces occluder, while those in the control group will receive a standard occluder.The safety and efficacy of the two groups at 1 year after surgery will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: ASD closure with the novel occluder (ReAces)Patients with ASD assigned to experimental group will receive the novel ASD occluder (ReAces) |
| Control Group | Active comparator | Device: ASD closure with normal occluderPatients with ASD assigned to control group will receive the normal occluder |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18-70 years;
- with congenital secundum atrial septal defect;
- the maximal ASD diameter was ≤38 mm;
- with atrial-level left-to-right shunt, with Qp/Qs shunt ratio ≥1.5:1, or TTE or clinical manifestations indicated the existence of defect that inducing overfilling of right atrium;
- the distance from the margin of defect to coronary sinus, atrioventricular (AV) valve, and right superior pulmonary vein (RSPV) was ≥5 mm, according to the echocardiography measurements;
Key exclusion criteria (19 listed)
- ostium primordium ASD and sinus venosus ASD.
- infective endocarditis and hemorrhagic disorders.
- active thrombosis.
- patients with severe pulmonary hypertension (mean pulmonary artery pressure measured by catheter > 30 mmHg) who are not taking targeted drugs
- patients with a porous atrial septal defect that cannot be completely occluded by a single occluder.
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 |
|---|---|---|
| ASD closure with the novel occluder (ReAces)Transcatheter closure atrial septal defect with the novel occluder (ReAces) | Device | Experimental group |
| ASD closure with normal occluderTranscatheter closure atrial septal defect with normal occluder | Device | Control Group |
Primary outcome
Successful rate of complete closure of atrial septal defect
Time frame: 0-360 days
The success rate of complete closure at 12 months after the procedure was used as the main efficacy index to evaluate the effectiveness of the novel atrial septal defect occluder ReAces, reflecting the long-term implantation effect of the device.
1 secondary outcome
Adverse events
Time frame: 0-360 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 42757893Fang Y, Li M, Zhang Z, Zhang C, Fang Z, Zhang D, Liu H, Pan W, Zhou D, Ge J. Comparison of a Novel Occluder Versus Traditional Occluder in Atrial Septal Defect: A Randomized Trial. J Am Heart Assoc. 2026 Sep 18:e045052. doi: 10.1161/JAHA.125.045052. Online ahead of print.
- Derived from this study: PubMed 39734195Fang Y, Hou K, Lin D, Zhou D, Pan W, Ge J. Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders. BMC Cardiovasc Disord. 2024 Dec 30;24(1):755. doi: 10.1186/s12872-024-04438-1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASD closure with the novel occluder (ReAces) and ASD closure with normal occluder in people with Atrial Septal Defect, run by Shanghai Zhongshan Hospital at 1 site in China.
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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 24 May 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenzhi Pan, Dr (+86 13774475922, peden@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful rate of complete closure of atrial septal defect (time frame: 0-360 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371366, which also lists 2 linked publications.
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 24 May 2022.