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

Last updated: May 17, 2022
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Pentalogy Of Cantrell

Treatment

N/A

Clinical Study ID

NCT05371366
HYYL2022-06ZC-01
  • Ages 18-70
  • All Genders

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.

Eligibility Criteria

Inclusion

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 orclinical manifestations indicated the existence of defect that inducing overfilling ofright 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 echocardiographymeasurements;
  6. volunteered to participate in this study, and signed informed consents.

Exclusion

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 measuredby catheter > 30 mmHg) who are not taking targeted drugs
  5. patients with a porous atrial septal defect that cannot be completely occluded by asingle 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 physicalcondition (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 takeother 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 thestudy's prescribed follow-up schedule
  17. Participation in another clinical trial of a drug or medical device within 30 daysprior to screening.
  18. Patients who have previously undergone surgical atrial septal defect repair orpercutaneous interventional atrial septal defect closure.
  19. Patients who, in the opinion of the investigator, are not suitable for participationin this study.

Study Design

Total Participants: 128
Study Start date:
April 22, 2022
Estimated Completion Date:
April 22, 2023

Connect with a study center

  • 180 Fenglin Road

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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