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NCT Number: NCT07696182

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

VOYAGER CE Clinical Study using the Encantor TAVI System.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prospective, single-arm, multi-center study.

Device

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.

Primary outcomes

  1. Composite of all-cause mortality or all strokes at 12 months post index

    Time frame: 12 months post index

    Composite of all-cause mortality or all strokes

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Harvey

CONTACT

[email protected]

Nadia Bouhdi

CONTACT

[email protected]

+32479941037

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: VOYAGER CE

Important dates

Study start
2026
Primary completion
2028
Study completion
2038
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.