Aortic Valve Stenosis, Severe Aortic Stenosis
Conditions
Keywords
Transcatheter Aortic Valve Replacement, TAVR, Transcatheter Aortic Valve Implantation, Aortic Valve Stenosis
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.
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
DEVICEInvestigational Transcatheter Aortic Valve Replacement System
Investigational transcatheter bioprosthetic aortic valve replacement system intended for treatment of severe symptomatic native aortic valve stenosis.
Sponsors
Onecrea Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Technical Success | At completion of the index procedure (exit from procedure room) | Technical success of the investigational transcatheter aortic valve replacement procedure as assessed according to the Clinical Investigation Plan and predefined study criteria. |
| Percentage of Participants With Device Success | 30 days after the procedure | Device success following implantation of the investigational transcatheter aortic valve replacement system as assessed according to the Clinical Investigation Plan using predefined performance criteria. |
| Percentage of Participants Free From Early Safety Events | 30 days after the procedure | Early safety of the investigational transcatheter aortic valve replacement system based on predefined clinical safety criteria specified in the Clinical Investigation Plan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality rate | Through 5 years | Assessment of all-cause mortality following implantation of the investigational transcatheter aortic valve replacement system |
| Cardiovascular Mortality Rate | Through 5 years | Assessment of cardiovascular mortality during follow-up. |
| Percentage of Participants Experiencing Stroke | Through 5 years | Assessment of stroke events occurring during the follow-up period |
| Rate of Valve- or Procedure-Related Rehospitalization | Through 5 years | Assessment of valve- or procedure-related rehospitalization during follow-up |
| Hemodynamic Valve Performance assessed by Echocardiography | Through 5 years | Assessment of prosthetic valve performance using echocardiographic evaluations |
| Change From Baseline in NYHA Functional Class | Baseline through 5 years | Change in New York Heart Association (NYHA) functional class following treatment. |
| Change From Baseline in Six-Minute Walk Test (6MWT) Distance | Baseline through 5 years | Change in six-minute walk test (6MWT) distance during follow-up. |
| Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Overall Summary Score | Baseline through 5 years | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score during follow-up |
| Percentage of Permanent Pacemaker Implantation | Through 5 years | Assessment of new permanent pacemaker implantation following the procedure |
Outcome results
None listed