Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR

ConditionsSevere Native Calcific Aortic Stenosis Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAbbott Medical Devices

About this trial

VOYAGER CE Clinical Study using the Encantor TAVI System.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Prospective, single-arm, multi-center study.

Treatment groups

150 Participants

are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Abbott Medical Devices

Lead sponsor

Source ClinicalTrials.gov