NCT06818435

Brief Summary

A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
May 2025Nov 2028

First Submitted

Initial submission to the registry

February 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 13, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

January 16, 2026

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 5, 2025

Last Update Submit

January 15, 2026

Conditions

Aortic Valve StenosisTAVI(Transcatheter Aortic Valve Implantation)

Keywords

MyPORTuValTAVIPortuguese TAVI Registry

Outcome Measures

Primary Outcomes (1)

  • Safety of Myval valve and TAVI procedure

    Composite of: * All-cause mortality * All stroke * Acute kidney injury (stage 2, 3 and 4) * Bleeding (Type 3 and 4) * Moderate or severe paravalvular leak * Major vascular complications * Conduction disturbances resulting in new permanent pacemaker implantation

    30 days

Secondary Outcomes (1)

  • Safety and Performance of Myval valve and TAVI procedure

    30 days and 12 Months

Interventions

Myval THV seriesDEVICE

Transcatheter Aortic Valve Implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with symptomatic severe native aortic valve stenosis who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.

You may qualify if:

  • Patient over the age of 18 years with symptomatic aortic stenosis (severe AS), intended to perform TAVI procedure using Myval THV series as assessed by Heart Team.
  • Patient has provided written informed consent as approved by the Ethics Committee (EC)
  • Patient is willing to undergo all registry procedures and follow-up requirements

You may not qualify if:

  • Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
  • Ongoing infective endocarditis or any similar infection.
  • Pregnant or lactating females.
  • Liver failure (Child-Pugh Class B or C)
  • Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.
  • Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz

Carnaxide, 2790-134, Portugal

RECRUITING

Unidade Local de Saúde de Coimbra

Coimbra, 3004-561, Portugal

RECRUITING

Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo

Evora, 7000-811, Portugal

RECRUITING

Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta

Lisbon, 1169-024, Portugal

NOT YET RECRUITING

Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

RECRUITING

Unidade Local de São João E.P.E.

Porto, 4200-319, Portugal

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Rui Campante Teles, Prof. Dr.

    Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz

    STUDY CHAIR

Central Study Contacts

Ana Domingues

CONTACT

+351217970685ana.domingues@spc.pt

Joana D Silva, MD

CONTACT

+351217970685joanadelgadosilva@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 10, 2025

Study Start

May 13, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

January 16, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(6)