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

NCT07696182 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-07-10

No results posted yet for this study

Summary

VOYAGER CE Clinical Study using the Encantor TAVI System.

Conditions

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

Interventions

DEVICE

Prospective, single-arm, multi-center study.

This intervention is distinguished by the use of the Encantor TAVI System, a transcatheter valve replacement therapy specifically designed for patients with symptomatic severe native calcific aortic stenosis who are considered appropriate candidates by a multidisciplinary heart team. This device is intended to provide a minimally invasive alternative to surgical aortic valve replacement.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ashish Oza · Abbott Structural Heart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-09-30
Completion
2038-12-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696182 on ClinicalTrials.gov