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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Investigational Transcatheter Aortic Valve Replacement System.
- Who it may be relevant to
- Registry conditions: Aortic Valve Stenosis, Severe Aortic Stenosis. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Severe symptomatic aortic valve stenosis is a progressive disease associated with significant morbidity and mortality if left untreated. Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for appropriately selected patients with severe native aortic valve disease who are considered suitable candidates for transcatheter intervention.
This clinical investigation is designed to evaluate an investigational transcatheter aortic valve replacement system developed for the treatment of severe symptomatic native aortic valve stenosis. The study will collect clinical evidence to assess the safety and performance of the investigational device in accordance with the Clinical Investigation Plan and applicable regulatory requirements.
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.
Primary outcome measures
- Percentage of Participants With Technical Success [Time frame: At completion of the index procedure (exit from procedure room)]
- Percentage of Participants With Device Success [Time frame: 30 days after the procedure]
- Percentage of Participants Free From Early Safety Events [Time frame: 30 days after the procedure]
Secondary outcome measures (9)
- All-cause Mortality rate [Time frame: Through 5 years]
- Cardiovascular Mortality Rate [Time frame: Through 5 years]
- Percentage of Participants Experiencing Stroke [Time frame: Through 5 years]
- Rate of Valve- or Procedure-Related Rehospitalization [Time frame: Through 5 years]
- Hemodynamic Valve Performance assessed by Echocardiography [Time frame: Through 5 years]
- Change From Baseline in NYHA Functional Class [Time frame: Baseline through 5 years]
- Change From Baseline in Six-Minute Walk Test (6MWT) Distance [Time frame: Baseline through 5 years]
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Overall Summary Score [Time frame: Baseline through 5 years]
- Percentage of Permanent Pacemaker Implantation [Time frame: Through 5 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07734025 · CT-XXXX-CAVS-2025