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

NCT05371366 | Unknown

• 1 other identifier: HYYL2022-06ZC-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

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.

  0-360 days

Secondary Outcomes (1)

• Adverse events

  0-360 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: ASD closure with the novel occluder (ReAces)

Control Group

ACTIVE COMPARATOR

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

Device: ASD closure with normal occluder

Interventions

ASD closure with the novel occluder (ReAces) DEVICE

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

Experimental group

ASD closure with normal occluder DEVICE

Transcatheter closure atrial septal defect with normal occluder

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Fang 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.

  PMID: 39734195 DERIVED

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Wenzhi Pan, Dr

CONTACT

+86 13774475922; peden@sina.com

Junbo Ge, Dr

CONTACT

+86 13901977506; ge.junbo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 12, 2022
• Study Start: April 22, 2022
• Primary Completion: April 22, 2023
• Study Completion: April 22, 2023
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)