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NCT07696182
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Conditions: Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Abbott Medical Devices
Summary
VOYAGER CE Clinical Study using the Encantor TAVI System.
Eligibility Criteria
Inclusion Criteria:
* Subject identified as appropriate for transcatheter heart valve intervention therapy for the treatment of symptomatic, severe aortic stenosis.
* Subject is of legal age for consent (18 years old).
* Willing to return for required follow-up visits and assessments
Exclusion Criteria:
* Pregnant or nursing subjects.
* Need for emergency surgery for any reason
* Anatomic or comorbid conditions
* Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this trial
Source: ClinicalTrials.gov (NCT07696182). StuddyBuddy aggregates publicly available trial information.
