Trials / Completed
CompletedNCT01960491
FIH Study With CBSO
Prospective Single Center Pilot Clinical Study to Evaluate the Safety and Effectiveness of an Intracardiac Septal Closure Device With Biodegradable Framework in Patients With Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Carag AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Device Closure of Atrial Septal Defect | Device Closure of Atrial Septal Defect by "Carag Bioresorbable Septal Occluder" |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2017-01-01
- Completion
- 2018-06-01
- First posted
- 2013-10-10
- Last updated
- 2018-10-11
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01960491. Inclusion in this directory is not an endorsement.