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

Primary Purpose

Atrial Septal Defect

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ASD closure with the novel occluder (ReAces)

ASD closure with normal occluder

About this trial

This is an interventional treatment trial for Atrial Septal Defect

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

180 Fenglin RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05371366

First Posted

May 4, 2022

Last Updated

May 17, 2022

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05371366

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 22, 2022 (Actual)

Primary Completion Date

April 22, 2023 (Anticipated)

Study Completion Date

April 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Septal Defect

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

ASD closure with the novel occluder (ReAces)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

ASD closure with normal occluder

Intervention Description

Transcatheter closure atrial septal defect with normal occluder

Primary Outcome Measure Information:

Title

Successful rate of complete closure of atrial septal defect

Description

Time Frame

0-360 days

Secondary Outcome Measure Information:

Title

Adverse events

Description

Time Frame

0-360 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenzhi Pan, Dr

Phone

+86 13774475922

peden@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Junbo Ge, Dr

Phone

+86 13901977506

ge.junbo@zs-hospital.sh.cn

Facility Information:

Facility Name

180 Fenglin Road

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenzhi Pan, Dr

Phone

+86 13774475922

peden@sina.com

First Name & Middle Initial & Last Name & Degree

Junbo Ge, Dr

Phone

+86 13901977506

ge.junbo@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD

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

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