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NCT07501234: MITRA-EFS
Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System
NA trial testing MitraFix® Transcatheter Mitral Valve System in Mitral Regurgitation (MR) in 5 participants. Currently enrolling.
23 March 2028
Quick facts
| Lead sponsor | Mitrassist Lifesciences Limited Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 5 |
| Start date | 23 March 2026 |
| Primary completion | 23 March 2028 |
| Estimated completion | 23 October 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- MitraFix® Transcatheter Mitral Valve System
Conditions studied
- Mitral Regurgitation (MR) — all drugs for Mitral Regurgitation (MR) →
Sponsor
Mitrassist Lifesciences Limited Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Mitral Regurgitation (MR). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System. It aims to learn if the device is safe and if it can help adults who have a severe leaky heart valve (mitral regurgitation). This study is for people who are at high risk for traditional open-heart surgery. The main questions it aims to answer are: Is the MitraFix system safe for participants? Can the device be successfully placed in the heart? Does the device help reduce the valve leak and improve daily life? Participants will: Receive the MitraFix valve through a small tube inserted into a vein in the leg. Visit the clinic for heart tests, walking tests, and health checks for up to one year after the procedure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07501234
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Mitral Regurgitation (MR)
Currently open trials in the same condition.
- NCT07197736 — DELINEATE-Prospective · recruiting
- NCT06816888 — Impact of Automatic Prompts in Echocardiographic Reports on Referral to Cardiology · NA · active not recruiting
- NCT06876883 — MItral Regurgitation Risk Assessment and CLinical modElling · recruiting
- NCT07045753 — The Prospective Segeberg Registry for Mitral Transcatheter Edge-to-Edge Repair · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07501234 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mitrassist Lifesciences Limited Co., Ltd.
- Last refreshed: 30 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07501234.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing