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

NCT07696182 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10647
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

transcatheter valve replacement therapy; symptomatic heart disease

Outcome Measures

Primary Outcomes (1)

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

  Composite of all-cause mortality or all strokes

  12 months post index

Study Arms (1)

Transcatheter valve replacement therapy

EXPERIMENTAL

Transcatheter valve replacement therapy

Device: Prospective, single-arm, multi-center study.

Interventions

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.

Transcatheter valve replacement therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

MeSH Terms

Interventions

Longitudinal Studies

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ashish Oza

  Abbott Structural Heart

  STUDY DIRECTOR

Central Study Contacts

Nadia Bouhdi

CONTACT

+32479941037; nadia.bouhdi@abbott.com

Lauren Harvey

CONTACT

lauren.harvey@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2038
• Last Updated: July 10, 2026

Record last verified: 2026-07