Trials / Active Not Recruiting
Active Not RecruitingNCT04289870
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
Prospective, Single Arm, Multi-center, First-in-human (FIH) Study to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft for the Treatment of Severe Tricuspid Regurgitation (TR)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Innoventric LTD · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Trillium™ | Trillium™ Stent Graft for Functional Tricuspid Valve Replacement |
Timeline
- Start date
- 2020-06-24
- Primary completion
- 2023-07-21
- Completion
- 2026-06-01
- First posted
- 2020-02-28
- Last updated
- 2025-03-07
Locations
9 sites across 4 countries: Belgium, Germany, Israel, Spain
Source: ClinicalTrials.gov record NCT04289870. Inclusion in this directory is not an endorsement.