Comparing the Myval heart valve with other valves for severe aortic valve stenosis

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 aortic valve stenosis that causes symptoms. Aortic valve stenosis is a narrowing of the main heart valve. The trial compares the Myval valve with the Sapien and Evolut valves, placed through a thin tube (TAVI).

Age

18 years or older

Sex

All sexes

Disease stage

Severe aortic valve stenosis that causes symptoms, in the person's own (native) valve.

Earlier treatment

The local Heart Team must judge that the person can have TAVI. The person must be able to receive each of the three study valves.

Main reasons for not taking part

• Not willing to give written consent, or legal heirs object to taking part
• Any condition that the study doctor thinks makes taking part unsafe

The registry criteria, word for word

What the trial wants to find out

The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.

The 4 groups in the trial

• Myval THV SeriesTreatment being tested

  Myval THV Series will include Myval/Myval Inception THVs or any subsequent advanced version commercially available at the study site. This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.

• Contemporary ValvesExisting treatment, for comparison

  * Sapien THV Series will consist of Sapien 3/Sapien 3 Ultra THVs or any subsequent advanced version commercially available at the study site. * Evolut THV Series will include Evolut R/Evolut PRO THVs or any subsequent advanced version commercially available at the study site. This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.

  Treatment: Contemporary Valves (Sapien THV Series and Evolut THV Series)

• Myval THV Series XL Nested RegistryTreatment being tested

  A non-randomised, nested registry of patients with anatomy of native aortic annulus suitable to be implanted with extra-large size of Myval THV series (30.5mm or 32mm) as per Heart Team assessment/Investigator's discretion is designed. The objective of this registry is to assess the safety and effectiveness of extra-large sizes of Myval THV series. Approximately 100 patients will be recruited from approximately 30 participating centres in LANDMARK Trial

  Treatment: Myval THV Series

• Myval THV Series Lead-in SetTreatment being tested

  The Lead-in Set aims to ensure investigators adhere to protocol requirements related to the Myval THV Series device, including imaging and procedural guidelines. Investigators should be independent before enrolling study subjects, allowing for valuable feedback for initial safety assessments. Each investigator must conduct at least two non-randomized lead-in cases under the guidance of an evaluation committee. Lead-in subjects will only receive the study device, and if implantation fails, standard care will be provided. These subjects will not be included in primary or secondary endpoint analyses but will undergo descriptive analysis. Unique numbers will be assigned to all lead-in subjects, and the committee will evaluate outcomes and site independence for future trial recruitment.

  Treatment: Myval THV Series