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Not yet recruiting NCT07696182

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

No phase Interventional Severe Native Calcific Aortic Stenosis Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prospective, single-arm, multi-center study..
Who it may be relevant to
Registry conditions: Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Composite of all-cause mortality or all strokes at 12 months post index [Time frame: 12 months post index]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07696182 · ABT-CIP-10647

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗