VISTA Post-Market Clinical Study

JRCT ID: jRCT1032240045

Registered date:24/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Aortic Stenosis
• Date of first enrollment: 29/09/2023
• Target sample size: 81
• Countries of recruitment: France,Japan,Germany,Japan,Italy,Japan,Portugal,Japan,Spain,Japan,Swwitzerland,Japan,UK,Japan,Canada,Japan,Australia,Japan
• Study type: Observational

Outcome(s)

Primary Outcome

Moderate or greater paravalvular leak at 30 days post-TAVI procedure [Time Frame: 30 days post ind
ex procedure]
All-cause mortality at 30 days post-TAVI procedure [Time Frame: 30 days post index procedure]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 100age old
• Gender: Both

Include criteria

- The patient is scheduled to undergo a Navitor TAVI procedure.
- The patient has been informed of the nature of the study, agrees to its provisions,and has provided written informed consent as approved by the IRB (InvestigationalReview Board)/EC (Ethics Committee) of the respe
ctive clinical site.
- The patient and the treating physician agree that the subject will return for all
required post procedure follow up visits.

Exclude criteria

Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
- In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
- Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.
- Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.
- Currently participating in an investigational drug or device study that may confound the results of this study

Related Information

• Primary Sponsor: Masumoto Naohiro
• Secondary ID(s): NCT06008080