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 | Not Yet Recruiting DMC

• 1 other identifier: CT-XXXX-CAVS-2025
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Transcatheter Aortic Valve Replacement; TAVR; Transcatheter Aortic Valve Implantation; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Technical Success

  Technical success of the investigational transcatheter aortic valve replacement procedure as assessed according to the Clinical Investigation Plan and predefined study criteria.

  At completion of the index procedure (exit from procedure room)

• Percentage of Participants With Device Success

  Device success following implantation of the investigational transcatheter aortic valve replacement system as assessed according to the Clinical Investigation Plan using predefined performance criteria.

  30 days after the procedure

• Percentage of Participants Free From Early Safety Events

  Early safety of the investigational transcatheter aortic valve replacement system based on predefined clinical safety criteria specified in the Clinical Investigation Plan.

  30 days after the procedure

Secondary Outcomes (9)

• All-cause Mortality rate

  Through 5 years

• Cardiovascular Mortality Rate

  Through 5 years

• Percentage of Participants Experiencing Stroke

  Through 5 years

• Rate of Valve- or Procedure-Related Rehospitalization

  Through 5 years

• Hemodynamic Valve Performance assessed by Echocardiography

  Through 5 years

Study Arms (1)

Investigational TAVR Device

EXPERIMENTAL

Participants will receive the investigational transcatheter aortic valve replacement (TAVR) system for the treatment of severe symptomatic native aortic valve stenosis according to the Clinical Investigation Plan.

Device: Investigational Transcatheter Aortic Valve Replacement System

Interventions

Investigational Transcatheter Aortic Valve Replacement System DEVICE

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

Investigational TAVR Device

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years or older.
• Symptomatic severe native calcific aortic valve stenosis.
• Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team.
• Considered at high surgical risk for surgical aortic valve replacement.
• Able to understand the study requirements and provide written informed consent.
• Willing and able to comply with all study procedures and follow-up visits.

You may not qualify if:

• Contraindication to transcatheter aortic valve replacement or the investigational procedure.
• Active infection or endocarditis.
• Life expectancy less than one year due to non-cardiac comorbidities.
• Participation in another investigational study that could interfere with the objectives of this study.
• Any medical, anatomical, or clinical condition that, in the opinion of the investigator or Heart Team, would make study participation inappropriate or place the subject at unacceptable risk.

Sponsors & Collaborators

• Onecrea Medical Inc.: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants will receive the investigational transcatheter aortic valve replacement system. This is a prospective, multicenter, single-arm pivotal clinical investigation designed to evaluate the safety and performance of the investigational device.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): December 4, 2026
• Primary Completion (Estimated): December 7, 2027
• Study Completion (Estimated): June 30, 2033
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share