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NCT06597188: PROMIS-BAV
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
NA trial testing VitaFlow Liberty in Aortic Stenosis in 452 participants. Enrolling by invitation.
30 September 2028
Quick facts
| Lead sponsor | Shanghai MicroPort CardioFlow Medtech Co., Ltd. |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 452 |
| Start date | 8 September 2025 |
| Primary completion | 30 September 2028 |
| Estimated completion | 30 September 2032 |
| Sites | 1 location across China |
Drugs / interventions tested
- VitaFlow Liberty
- Commercially available surgical bioprosthetic valve
Conditions studied
- Aortic Stenosis — all drugs for Aortic Stenosis →
- Bicuspid Aortic Valve (BAV) — all drugs for Bicuspid Aortic Valve (BAV) →
Sponsor
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Who can join
Adults 18 to 75, any sex, with Aortic Stenosis or Bicuspid Aortic Valve (BAV). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06597188
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Aortic Stenosis
Currently open trials in the same condition.
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- NCT07144189 — AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography · recruiting
Other Shanghai MicroPort CardioFlow Medtech Co., Ltd. trials
Trials by the same sponsor.
- NCT07304427 — Alwide Plus China Post-market Clinical Investigation · completed
- NCT05977257 — VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL） · not yet recruiting
- NCT04414865 — VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study · recruiting
- NCT04414878 — VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial · NA · recruiting
- NCT04655742 — VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial · NA · unknown
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 NCT06597188 (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 Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Last refreshed: 16 September 2025
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/NCT06597188.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing