Trials / Recruiting
RecruitingNCT06008080
Post-Market Clinical Follow Up Study With Navitor Valve
VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Detailed description
The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System | Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System |
Timeline
- Start date
- 2023-09-29
- Primary completion
- 2026-09-01
- Completion
- 2031-12-01
- First posted
- 2023-08-23
- Last updated
- 2025-06-06
Locations
35 sites across 10 countries: Australia, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06008080. Inclusion in this directory is not an endorsement.