NCT04395027 (iASD) is a Phase 3 clinical trial of atrial septal defect closure in Septal Defect, Atrial, sponsored by Henry Ford Health System.

Who is sponsoring NCT04395027?

NCT04395027 is sponsored by Henry Ford Health System.

What drugs are being tested in NCT04395027?

Interventions in NCT04395027: atrial septal defect closure.

What condition does NCT04395027 study?

NCT04395027 studies Septal Defect, Atrial.

Is NCT04395027 still recruiting?

NCT04395027 is currently withdrawn. Last updated 8 December 2022.

Last reviewed 2022-12-08 · How we verify

NCT04395027: iASD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Iatrogenic Atrial Septal Defect Study (iASD)

Withdrawn Phase 3 Last updated 8 December 2022

What this trial tests

Phase 3 trial testing atrial septal defect closure in Septal Defect, Atrial. Withdrawn.

Timeline

6 May 2020

Primary endpoint
22 March 2022

22 March 2022

Quick facts

Lead sponsor	Henry Ford Health System
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	6 May 2020
Primary completion	22 March 2022
Estimated completion	22 March 2022
Sites	1 location across United States

Drugs / interventions tested

atrial septal defect closure

Conditions studied

Septal Defect, Atrial — all drugs for Septal Defect, Atrial →

Sponsor

Henry Ford Health System — full company profile →

Who can join

18 and older, any sex, with Septal Defect, Atrial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04395027 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Henry Ford Health System
Last refreshed: 8 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04395027.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing