Trials / Completed
CompletedNCT04417712
Lifetech KONAR MFO Post-Market Clinical Follow-Up Study
Lifetech KONAR-MF™ VSD Occluder Post-Market Clinical Follow-Up Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to collect real-world data on patient outcomes and evaluate the procedural success and performance of the Lifetech KONAR-MF™ VSD Occluder for patients with ventricular septal defect (VSD).
Detailed description
This is a non-randomized prospective post-marketing clinical follow-up study (PMCFS) in order to evaluate the feasibility and safety of the Lifetech KONAR-MF™ VSD Occluder device used for patients with ventricular septal defect. The implantation should be performed in accordance with the instructions for use (IFU).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | KONAR-MF™ VSD Occluder | All patients will be implanted with a KONAR-MF™ VSD Occluder in accordance with the instructions for use (IFU). |
Timeline
- Start date
- 2019-12-04
- Primary completion
- 2022-03-30
- Completion
- 2023-06-30
- First posted
- 2020-06-05
- Last updated
- 2024-04-15
Locations
4 sites across 2 countries: Germany, Italy
Source: ClinicalTrials.gov record NCT04417712. Inclusion in this directory is not an endorsement.