Status:
UNKNOWN
The Puncturable Atrial Septal Defect Occluder Trial (the PASSER Trial)
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Atrial Septal Defect
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 septa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2023
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05371366
Start Date
April 22 2022
End Date
April 22 2023
Last Update
May 24 2022
Active Locations (1)
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1
180 Fenglin Road
Shanghai, Shanghai Municipality, China, 200032