Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCeric Sàrl
About this trial
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
Eligibility criteria
Qualifiers
Patient above 18 years of age.
Patients must have co-morbidities such that the heart team and Investigator concur that the predicted risk of operative mortality is high.
Echocardiographically derived criteria: regurgitant volume ≥60 ml/beat, regurgitant fraction ≥50%, effective regurgitant orifice ≥0.3cm2, holodiastolic flow reversal at the level of the mid-descending aorta with an end diastolic flow velocity greater than 20 cm/s, width of vena contracta ≥6mm, hemi pressure time <200 msec, or vena contracta area assessed with 3D echo ≥0.4 cm².
Cardiac magnetic resonance derived criteria: Regurgitant fraction >40% or regurgitant volume >60mL.
Disqualifiers
Patients who are not willing to provide informed consent form, or whose legal heirs object to participate in the study
Pregnant and lactating female patients
Evidence of an acute myocardial infarction ≤1 month before the intended treatment
Mixed aortic valve disease
Trial design
Treatments tested in this trial
- Myval THV series
Treatment groups
164 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov