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Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR

ConditionsAortic RegurgitationAortic DiseaseCalcified Aortic Valve
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Myval THV series

    Device

    All patients with severe symptomatic non- or mild-calcified aortic regurgitation undergoing TAVR using Myval THV series in high surgical risk based on investigator/Heart team discretion who meet study eligibility criteria.

Treatment groups

164 Participants
are divided into 1 treatment group
Group A: Single ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

All cause mortality

Death due to any cause occurring during the specified follow-up period.

Time frame
30 days
2

All Stroke

Any ischemic or hemorrhagic stroke confirmed by clinical evaluation and/or appropriate imaging during follow-up.

Time frame
30 days
3

Bleeding (Type 3 & 4)

Major bleeding events classified as Bleeding Academic Research Consortium (BARC) Type 3 or Type 4.

Time frame
30 days
4

Major vascular complications

Major vascular access- or procedure-related complications as defined by the Valve Academic Research Consortium (VARC) criteria.

Time frame
30 days

Secondary outcomes

1

All cause mortality

Death due to any cause occurring during the specified follow-up period.

Time frame
6 months, 1 year, 2 years, 3 years, 4 years and 5 years
2

All Stroke

Any ischemic or hemorrhagic stroke confirmed by clinical evaluation and/or appropriate imaging during follow-up.

Time frame
1 years, 3 years and 5 years
3

Bleeding (Type 3 & 4)

Major bleeding events classified as Bleeding Academic Research Consortium (BARC) Type 3 or Type 4.

Time frame
1 year, 3 years and 5 years
4

Surgery/Intervention related to device

Any unplanned surgical or catheter-based intervention performed to correct or treat a device-related complication.

Time frame
1 year, 3 years and 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ceric Sàrl

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: