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Iatrogenic Atrial Septal Defect Study (iASD)

NCT04395027 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-12-08

No results posted yet for this study

Summary

This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access.

Conditions

  • Septal Defect, Atrial

Interventions

DEVICE

atrial septal defect closure

The iatrogenic septal defect will be closed in the usual manner

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Marvin Eng, MD · Henry Ford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-06
Primary Completion
2022-03-22
Completion
2022-03-22
FDA Device
Yes

Countries

  • United States

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 NCT04395027 on ClinicalTrials.gov