Last reviewed · How we verify
NCT05902897
Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
trial testing Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis. in Aortic Valve Insufficiency in 913 participants. Completed in 30 October 2023.
1 July 2023
Quick facts
| Lead sponsor | Braile Biomedica Ind. Com. e Repr. Ltda. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 913 |
| Start date | 1 January 2023 |
| Primary completion | 1 July 2023 |
| Estimated completion | 30 October 2023 |
| Sites | 3 locations across Brazil |
Drugs / interventions tested
- Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.
Conditions studied
- Aortic Valve Insufficiency — all drugs for Aortic Valve Insufficiency →
- Aortic Valve Regurgitation — all drugs for Aortic Valve Regurgitation →
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
- Aortic Valve Incompetence — all drugs for Aortic Valve Incompetence →
Sponsor
Braile Biomedica Ind. Com. e Repr. Ltda.
Who can join
18 and older, any sex, with Aortic Valve Insufficiency or Aortic Valve Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05902897
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Aortic Valve Insufficiency
Currently open trials in the same condition.
- NCT06235385 — European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study · recruiting
- NCT05295628 — Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR · NA · active not recruiting
- NCT06034028 — J-Valve TF Early Feasibility Study · NA · active not recruiting
- NCT05572710 — Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population · recruiting
- NCT04281771 — Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI · NA · active not recruiting
Other Braile Biomedica Ind. Com. e Repr. Ltda. trials
Trials by the same sponsor.
- NCT06959836 — Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve · completed
- NCT06270537 — Post-market Clinical Trial of the Dominus® Stent-Graft · recruiting
- NCT05531578 — Transfemoral Implant of Inovare® Transcatheter Valve · NA · active not 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 NCT05902897 (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 Braile Biomedica Ind. Com. e Repr. Ltda.
- Last refreshed: 25 April 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/NCT05902897.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing