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Atrial Septal Occluder

atrial septal defect closure for Atrial Septal Defect (iASD Trial)

Phase 3
Waitlist Available
Led By Marvin Eng, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 at the time of informed consent signature.
Capable of complying with Protocol requirements, including follow-up.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

iASD Trial Summary

This trial is testing whether closing an iatrogenic atrial septal defect (a hole in the heart) with an occluder device is better than usual care observation in patients who have had a mitral valve intervention and need large-bore transspetal access.

Eligible Conditions
  • Atrial Septal Defect

iASD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

iASD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Freedom from heart failure hospitalization
NYHA Functional Class
survival

iASD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DeviceExperimental Treatment1 Intervention
These patients will have their iatrogenic septal defect closed after the mitral intervention is completed.
Group II: Usual careActive Control1 Intervention
These patients will not have their iatrogenic septal defect closed.

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,999 Total Patients Enrolled
Marvin Eng, MDPrincipal Investigator - Henry Ford Hospital
Henry Ford Health System, Henry Ford Hospital, Henry Ford Macomb Hospital, Henry Ford West Bloomfield Hospital
Wayne State University School Of Medicine (Medical School)
University Co Hlth Sci Center (Residency)
1 Previous Clinical Trials
150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more slots open for this clinical trial?

"That is correct. The information available on clinicaltrials.gov verifies that this clinical trial is recruiting patients. This particular study was posted on 05/06/2020 and was updated as recently as 05/15/2020. They are hoping to enroll 210 individuals from a single site."

Answered by AI

How many people are being accepted into this clinical trial at most?

"The listing on clinicaltrials.gov verifies that this study is actively seeking participants. It was first posted on May 6th, 2020, with the 210 patients needed coming from a single location."

Answered by AI

Has the FDA cleared atrial septal defect closure for public use?

"Previous clinical trials have collected data supporting the efficacy of atrial septal defect closure, so it received a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Iatrogenic Atrial Septal Defect Study (iASD)
Tiberio Frisoli 2020. "Iatrogenic Atrial Septal Defect Study (iASD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04395027.
~0 spots leftby Apr 2025
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