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NCT04591392 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
A NA study of Cardiovascular Diseases and Heart Diseases, sponsored by atHeart Medical.
- Active
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT04591392: Active NA study of Cardiovascular Diseases and Heart Diseases, sponsored by atHeart Medical.
NCT04591392 is a NA study of Cardiovascular Diseases and Heart Diseases that is active but no longer recruiting, run by atHeart Medical. The registered enrollment target is 250 participants, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04591392, a NA study of Cardiovascular Diseases and Heart Diseases, is active but no longer recruiting, sponsored by atHeart Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
Primary Outcome
1. Clinically effective ASD closure, defined as no residual ASD or clinically insignificant residual ASD as determined by core laboratory review; and 2. No re-intervention to treat the defect; and 3. No device or procedure related serious adverse event.
Conditions Studied
Interventions
- DEVICE reSept ASD Occluder
Study Locations (20)
California
- Children's Hospital of Los Angeles - Los Angeles
- Los Robles Regional Medical Center - Thousand Oaks
Michigan
- University of Michigan - Ann Arbor
- Children's Hospital of Michigan - Detroit
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Nationwide Children's Hospital - Columbus
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- UPMC Children's Hospital of Pittsburgh - Pittsburgh
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Yale University - New Haven
Florida
- Joe DiMaggio Children's Hospital/Memorial Healthcare System - Hollywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-03-12 |
| Est. Completion | 2032-03 |
| Phase | NA |
What the registry record for NCT04591392 still lists
NCT04591392 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower).
The record links to 7 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which reSept ASD Occluder is the first listed.
NCT04591392 names 20 study sites across 16 states, led by California, Michigan, Ohio.
Frequently Asked Questions
What is clinical trial NCT04591392 about?
NCT04591392 is a clinical study titled "Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD". Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
What is the current status of trial NCT04591392?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2021-03-12. Estimated completion is 2032-03.
What conditions does trial NCT04591392 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Heart Diseases, Heart Defects, Congenital, Cardiovascular Abnormalities, Congenital Abnormalities.
What interventions are being tested in trial NCT04591392?
The interventions under investigation include: reSept ASD Occluder (DEVICE).
Who is sponsoring clinical trial NCT04591392?
This trial is sponsored by atHeart Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04591392 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04591392's enrollment target sits among peer trials
250 133rd of 300 higher than 164 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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