Trials / Unknown
UnknownNCT03373929
Stitch Closure of PFO and Septal Repair
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- HeartStitch.Com · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and PFO.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PFO Closure Rate | Suture Mediated PFO Closure and Septal Repair |
| DEVICE | Published PFO Device Closure | Suture Mediated PFO Closure and Septal Repair |
Timeline
- Start date
- 2017-11-20
- Primary completion
- 2019-11-20
- Completion
- 2022-11-20
- First posted
- 2017-12-14
- Last updated
- 2017-12-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03373929. Inclusion in this directory is not an endorsement.