CClinicalTrials.gg
Status unknownNCT05371366Updated May 24, 2022

The Puncturable Atrial Septal Defect Occluder Trial (the PASSER Trial)

An interventional study of ASD closure with the novel occluder (ReAces) and ASD closure with normal occluder in Atrial Septal Defect, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Atrial Septal Defect
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In context

Heart Septal Defects

82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.

This study's planned enrollment of 128 is above the median of 72 across 51 interventional studies indexed under Heart Septal Defects.

Browse Heart Septal Defects studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. aged 18-70 years;
  2. with congenital secundum atrial septal defect;
  3. the maximal ASD diameter was ≤38 mm;
  4. 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;
  5. 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;
  6. volunteered to participate in this study, and signed informed consents.

Exclusion criteria

Exclusion Criteria:

  1. ostium primordium ASD and sinus venosus ASD.
  2. infective endocarditis and hemorrhagic disorders.
  3. active thrombosis.
  4. patients with severe pulmonary hypertension (mean pulmonary artery pressure measured by catheter > 30 mmHg) who are not taking targeted drugs
  5. patients with a porous atrial septal defect that cannot be completely occluded by a single occluder.
  6. with severe myocardial disorders or valvular disease not associated with ASD
  7. infectious disease within the last 1 month, or uncontrolled infectious disease
  8. bleeding disorders, untreated gastric or duodenal ulcers
  9. thrombosis in left atrium
  10. partial or total pulmonary vein ectopic drainage
  11. left atrial septum, left atrial or left ventricular dysplasia
  12. Patients whose size (too small for TEE probe, catheter size, etc.) or physical condition (active infection, etc.) makes them unsuitable for cardiac catheterization
  13. Patients who are allergic to nickel
  14. Patients with any contraindication to aspirin therapy (except for those able to take other antiplatelet agents for 6 consecutive months).
  15. Pregnant or lactating women and those who plan to become pregnant during the trial
  16. Patients with a life expectancy of \<12 months or those who are unable to complete the study's prescribed follow-up schedule
  17. Participation in another clinical trial of a drug or medical device within 30 days prior to screening.
  18. Patients who have previously undergone surgical atrial septal defect repair or percutaneous interventional atrial septal defect closure.
  19. Patients who, in the opinion of the investigator, are not suitable for participation in this study.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Patients with ASD assigned to experimental group will receive the novel ASD occluder (ReAces)

    Device: ASD closure with the novel occluder (ReAces)

  • Active comparator
    Control Group

    Patients with ASD assigned to control group will receive the normal occluder

    Device: ASD closure with normal occluder

Interventions

  • DeviceASD closure with the novel occluder (ReAces)

    Transcatheter closure atrial septal defect with the novel occluder (ReAces)

  • DeviceASD closure with normal occluder

    Transcatheter closure atrial septal defect with normal occluder

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 0-360 days

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05371366
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Junbo Ge (Principal Investigator, Shanghai Zhongshan Hospital) — Principal investigator
First posted
May 12, 2022
Start date
Apr 22, 2022
Primary completion
Apr 22, 2023 (estimated)
Completion
Apr 22, 2023 (estimated)
Last update
May 24, 2022

Study contacts

Wenzhi Pan, Dr
Contact
peden@sina.com
+86 13774475922
Junbo Ge, Dr
Contact
ge.junbo@zs-hospital.sh.cn
+86 13901977506

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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