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A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve

NCT07734025 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-29

No results posted yet for this study

Summary

This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan.

The study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.

Conditions

  • Aortic Valve Stenosis
  • Severe Aortic Stenosis

Interventions

DEVICE

Investigational Transcatheter Aortic Valve Replacement System

Investigational transcatheter bioprosthetic aortic valve replacement system intended for treatment of severe symptomatic native aortic valve stenosis.

Sponsors & Collaborators

  • Onecrea Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-04
Primary Completion
2027-12-07
Completion
2033-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734025 on ClinicalTrials.gov