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Clinical trial

Evaluation of the Safety and Clinical Performance of the Next-Generation SAFESYNC Balloon-Expandable Transcatheter Heart Valve in Patients With Severe Aortic Stenosis: A Prospective, Multicenter, Single-Arm Pivotal Study

NCT07806409 is registered in ClinicalTrials.gov with Braile Biomedica Ind. Com. e Repr. Ltda. as lead sponsor.

NCT NCT07806409
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Registry record

As filed in ClinicalTrials.gov.

Title
Evaluation of the Safety and Clinical Performance of the Next-Generation SAFESYNC Balloon-Expandable Transcatheter Heart Valve in Patients With Severe Aortic Stenosis: A Prospective, Multicenter, Single-Arm Pivotal Study
Lead sponsor
Braile Biomedica Ind. Com. e Repr. Ltda.
Phase
Not applicable
Overall status
Not yet recruiting
Start date
November 30, 2026
Completion date
June 30, 2032
Enrollment
40 (estimated)
Sites
Not reported

Conditions

As the registry lists them; a condition with its own page is linked.

aortic stenosis, aortic stenosis senile, aortic stenosis symptomatic