Last reviewed · How we verify

NCT05989074

All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve

Status unknown NA Last updated 12 January 2024
What this trial tests

NA trial testing ALLEGRA TAVI System TF in Aortic Stenosis, Severe in 130 participants. Status unknown.

Timeline
1 February 2024
Primary endpoint
31 August 2025
31 August 2025

Quick facts

Lead sponsorCeric Sàrl
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeother
Enrollment130
Start date1 February 2024
Primary completion31 August 2025
Estimated completion31 August 2025

Drugs / interventions tested

Conditions studied

Sponsor

Ceric Sàrl

Who can join

75 and older, female only, with Aortic Stenosis, Severe. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The TAVI Dilemma: Balloon-Expandable or Self-Expanding Transcatheter Heart Valve-Interpreting Current Evidence for Personalized Valve Selection.
    Vlachakis PK, Theofilis P, Kachrimanidis I, Soulaidopoulos S, et al · · 2025 · cited 2× · PMID 40869477 · DOI 10.3390/jcm14165651

Verify or expand the search:

Other recruiting trials for Aortic Stenosis, Severe

Currently open trials in the same condition.

Other Ceric Sàrl trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT05989074.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing