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NCT06212050: Neo2BAV
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
trial testing Transcatheter Aortic Valve Implantation in Aortic Stenosis in 200 participants. Enrolling by invitation.
1 March 2024
Quick facts
| Lead sponsor | National University of Ireland, Galway, Ireland |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 15 September 2023 |
| Primary completion | 1 March 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 3 locations across Sweden, Ireland, Germany |
Drugs / interventions tested
- Transcatheter Aortic Valve Implantation
Conditions studied
- Aortic Stenosis — all drugs for Aortic Stenosis →
- Transcatheter Aortic Valve Implantation — all drugs for Transcatheter Aortic Valve Implantation →
- Bicuspid Aortic Valve — all drugs for Bicuspid Aortic Valve →
- Transcatheter Aortic Valve Replacement — all drugs for Transcatheter Aortic Valve Replacement →
Sponsor
National University of Ireland, Galway, Ireland
Who can join
18 and older, any sex, with Aortic Stenosis or Transcatheter Aortic Valve Implantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis. The clinical, procedural, and imaging characteristics will be collected from patients with severe BAV stenosis, regardless of the phenotype, and treated with TAVI using the ACURATE neo2 bioprosthesis worldwide.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06212050
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other National University of Ireland, Galway, Ireland trials
Trials by the same sponsor.
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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 NCT06212050 (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 National University of Ireland, Galway, Ireland
- Last refreshed: 21 June 2024
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/NCT06212050.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing