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A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions

NCT04096924 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-09-20

No results posted yet for this study

Summary

Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). To precise the function of this device on reducing technical difficulties and conquering learning curves, it is required that the doctor should be able to independently do echo-guided percutaneous interventions and his cases should be more than 20 but less than 100. Experimental group is allocated to use novel interventional guidewire for echocardiography guided percutaneous interventions for ASD, control group will be treated by cook lunderquist guidewire. If echo-guided procedure does not work well, the procedure will be immediately replaced by conventional procedure guided by radiology. To evaluate the effectiveness and safety comprehensively, variables are defined as success rate, duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels etc.

Conditions

  • Atrial Septal Defect

Interventions

DEVICE

Guidewire for echo-guided interventions

Under echocardiography guided treatment of ASD with a novel interventional guidewire

DEVICE

Cook lunderquist guidewire

Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-07
Primary Completion
2019-12-30
Completion
2020-05-30

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 NCT04096924 on ClinicalTrials.gov