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A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure

NCT03941691 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2019-05-08

No results posted yet for this study

Summary

The purpose of this clinical trial is to verify the safety and effectiveness of the Fully Absorbable VSD Occlusion System and VSD Occlusion System produced by Shanghai shape memory alloy materials co., LTD. Clinical trials are designed as prospective, multicenter, randomized controlled, noninferiority clinical trials. Prospective randomized multicenter trial involving about 108 subjects will be enrolled in 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The success rate of occlusion at 6 months after operation is the main evaluation index in this clinical trial.

Conditions

  • Ventricular Septal Defect

Interventions

DEVICE

Fully Absorbable VSD Occlusion System

Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system

DEVICE

VSD Occluder

Under echocardiography guided treatment of VSD with commercially available occluder.

Sponsors & Collaborators

  • Shanghai Shape Memory Alloy Co., Ltd.

    collaborator UNKNOWN

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

  • Pan Xiangbin, MD, Ph.D · Chinese Academy of Medical Science, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-11
Primary Completion
2021-04-20
Completion
2021-04-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941691 on ClinicalTrials.gov