Trials / Active Not Recruiting
Active Not RecruitingNCT04591392
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- atHeart Medical · Industry
- Sex
- All
- Age
- 84 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
Detailed description
Prospective, three-stage, single arm, multi-site, clinical investigation evaluating the safety and efficacy of the reSept ASD Occluder in treating clinically significant secundum ASD. Outcomes/endpoints of the clinical investigation will be compared with established performance goals for FDA approved transcatheter secundum ASD occluders.
Conditions
- Heart Septal Defect
- Heart Septal Defects, Atrial
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Cardiovascular Diseases
- Heart Diseases
- Congenital Abnormalities
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | reSept ASD Occluder | Transcatheter closure of secundum ASD using a permanent implant |
Timeline
- Start date
- 2021-03-12
- Primary completion
- 2027-03-01
- Completion
- 2032-03-01
- First posted
- 2020-10-19
- Last updated
- 2025-05-07
Locations
32 sites across 4 countries: United States, Canada, France, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04591392. Inclusion in this directory is not an endorsement.