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Software-guided heart valve replacement for severe calcific aortic stenosis

Tests software-guided valve replacement in adults with severe aortic valve narrowing.

Key facts

Who runs it
Abbott Medical Devices
Where
Coimbra, PortugalSee the siteAlso in 7 other countries, 35 sites
Trial code
Registry title
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Status
Not yet recruiting
People taking part
300 people, planned
Starts
30 Nov 2026
Expected to end
30 Dec 2038
Type of study
Interventional
Treatments tested
  • Transcatheter valve replacement therapy
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe narrowing of the aortic heart valve that causes symptoms. Their doctors must judge that a valve replaced through a catheter (TAVI) is a fitting treatment for them.

Age
18 years and older
Sex
All sexes
Disease stage
Symptomatic, severe aortic stenosis (narrowing of the aortic valve), with calcium build-up on the person's own valve.

Main reasons for not taking part

  • Pregnant or breastfeeding
  • Needs emergency surgery for any reason
  • Body structure (anatomy) or other illnesses that rule out the procedure
  • Currently in another study of an experimental drug or device that has not reached its main endpoint or could affect this trial's results

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Need for emergency surgery for any reason
  • Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this trial
  • Anatomic or comorbid conditions
  • Pregnant or nursing subjects

Where in Portugal

Also in 7 other countries, 35 sites

  • Hospitais da universidade de CoimbraCoimbra, PortugalContact: Nadia BouhdiNo longer taking part

About the trial

What the trial wants to find out

VOYAGER CE Clinical Study using the Encantor TAVI System.

The group in the trial

  • Encantor TAVI SystemTreatment being tested

    The Encantor System is intended to treat patients with symptomatic severe aortic stenosis via transcatheter aortic valve implantation (TAVI)

    Treatment: Transcatheter valve replacement therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
VOYAGER CE Clinical Trial : Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
Plain-language title
Software-guided heart valve replacement for severe calcific aortic stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
12 November 2026