Trials / Unknown
UnknownNCT02737150
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 444 (actual)
- Sponsor
- Helios Health Institute GmbH · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CoreValve Evolut R | |
| DEVICE | Edwards Sapien 3 | |
| PROCEDURE | Local anesthesia with conscious sedation | |
| PROCEDURE | General anesthesia |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2019-02-01
- Completion
- 2021-04-01
- First posted
- 2016-04-13
- Last updated
- 2021-02-18
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02737150. Inclusion in this directory is not an endorsement.