# Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)

> **NCT07454980** · NA · NOT_YET_RECRUITING · sponsor: **Jenscare Innovation Inc.** · enrollment: 680 (estimated)

## Conditions studied

- Tricuspid Regurgitation (TR)

## Interventions

- **DEVICE:** TTVI with LuX-Valve Plus System
- **DEVICE:** TTVI with EVOQUE

## Key facts

- **NCT ID:** NCT07454980
- **Lead sponsor:** Jenscare Innovation Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-05
- **Primary completion:** 2029-12
- **Final completion:** 2038-12
- **Target enrollment:** 680 (ESTIMATED)
- **Last updated:** 2026-03-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07454980

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07454980, "Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT07454980. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*