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Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD

NCT04591392 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-05-07

No results posted yet for this study

Summary

Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect

Conditions

  • Heart Septal Defect
  • Heart Septal Defects, Atrial
  • Heart Defects, Congenital
  • Cardiovascular Abnormalities
  • Cardiovascular Diseases
  • Heart Diseases
  • Congenital Abnormalities

Interventions

DEVICE

reSept ASD Occluder

Transcatheter closure of secundum ASD using a permanent implant

Sponsors & Collaborators

  • atHeart Medical

    lead INDUSTRY

Principal Investigators

  • Thomas Forbes, MD · Joe DiMaggio Children's Hospital/Memorial Healthcare

  • Saibal Kar, MD · Los Robles Regional Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2027-03-31
Completion
2032-03-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • France
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT04591392 on ClinicalTrials.gov