Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

transcatheter valve replacement therapysymptomatic 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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).

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

MeSH Terms

Interventions

Longitudinal Studies

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment 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

November 30, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

September 30, 2028

Estimated

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Transcatheter valve replacement therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Transcatheter valve replacement therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record