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

VOYAGER CE Clinical Trial : Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07696182

Acronym

VOYAGER CE

Enrollment

150

Registered

2026-07-10

Start date

2026-11-30

Completion date

2038-12-30

Last updated

2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

transcatheter valve replacement therapy, symptomatic heart disease

Brief summary

VOYAGER CE Clinical Study using the Encantor TAVI System.

Detailed description

The VOYAGER CE trial is a prospective, single-arm, multi-center, pre-market clinical investigation designed to evaluate the safety and performance of the Encantor TAVI System. This clinical trial will enroll subjects who have symptomatic heart disease due to severe native calcific aortic stenosis and who are judged by a heart team to be appropriate for transcatheter valve replacement therapy.

Interventions

DEVICEProspective, 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Composite of all-cause mortality or all strokes at 12 months post index	12 months post index	Composite of all-cause mortality or all strokes

Contacts

CONTACTNadia Bouhdi

nadia.bouhdi@abbott.com+32479941037

CONTACTLauren Harvey

lauren.harvey@abbott.com

STUDY_DIRECTORAshish Oza

Abbott Structural Heart

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026