An interventional study of Myval THV series in Aortic Regurgitation, Aortic Disease and Calcified Aortic Valve, sponsored by Ceric Sàrl. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Ceric Sàrl · Not applicable, Interventional, and Treatment
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.
Severe symptomatic aortic regurgitation (AR) in high-risk or inoperable patients with non- or mildly calcified valves has limited treatment options. While TAVR has emerged as a viable approach in aortic stenosis, its use in aortic regurgitation remains limited due to anatomical complexities, the absence of dedicated devices, and the prevalence of large annular dimensions in these patients.Dedicated devices like the JenaValve Trilogy™ demonstrated safety and efficacy in trials such as ALIGN-AR and JUPITER registry, but use is restricted by annular size limitations.Additionally, The PANTHEON International Project demonstrated safety and efficacy of balloon and self-expandable valves in severe AR patients. Despite improved THV platforms and techniques, TAVR for pure native aortic valve regurgitation remains a challenging procedure, with significant risk for transcatheter valve embolization or migration (TVEM).The Myval THV series offers a broader size range from 20mm-35mm and allows for controlled oversizing, as demonstrated in a large international registry showing high technical success and favorable 1-year outcomes in patients with non-calcified AR.
169 studies on the registry are indexed under Aortic Valve Insufficiency; 54 are open to participants now.
This study's planned enrollment of 164 is above the median of 123 across 92 interventional studies indexed under Aortic Valve Insufficiency.
Browse Aortic Valve Insufficiency studies →Ceric Sàrl is the lead sponsor of 17 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient has non- or mild-calcified aortic regurgitation, undergoing TAVI with Myval THV Series without any degree stenosis, and severe aortic regurgitation as per investigator/ Heart team discretion according to (at least one) imaging criteria that can include:
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.
AND/OR
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Myval THV series
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.
All cause mortality
Death due to any cause occurring during the specified follow-up period.
Time frame: 30 days
All Stroke
Any ischemic or hemorrhagic stroke confirmed by clinical evaluation and/or appropriate imaging during follow-up.
Time frame: 30 days
Bleeding (Type 3 & 4)
Major bleeding events classified as Bleeding Academic Research Consortium (BARC) Type 3 or Type 4.
Time frame: 30 days
Major vascular complications
Major vascular access- or procedure-related complications as defined by the Valve Academic Research Consortium (VARC) criteria.
Time frame: 30 days
Acute Kidney Injury (Stage 3 and 4)
Acute kidney injury meeting Stage 3 or Stage 4 severity according to the applicable VARC/AKI classification criteria.
Time frame: 30 days
Surgery/Intervention related to device
Any unplanned surgical or catheter-based intervention performed to correct or treat a device-related complication.
Time frame: 30 days
Conduction system disturbances resulting in a new permanent pacemaker implantation
New conduction abnormalities requiring implantation of a permanent pacemaker after the index procedure.
Time frame: 30 days
Greater than or equal to Moderate Paravalvular Regurgitation
Presence of moderate or severe paravalvular regurgitation as determined by echocardiographic assessment during follow-up.
Time frame: 30 days
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
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
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
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
Conduction system disturbances resulting in a new permanent pacemaker implantation
New conduction abnormalities requiring implantation of a permanent pacemaker after the index procedure and during follow up
Time frame: 1 year, 3 years and 5 years
Re-hospitalization for procedure-related or valve-related causes
Any unplanned hospital admission due to complications related to the index procedure or the implanted valve during the follow-up period.
Time frame: 30 days, 1 year, 3 years and 5 years
NYHA functional improvement
Improvement or change in New York Heart Association (NYHA) functional class from baseline during the follow-up period.
Time frame: 30 days, 1 year, 3 years and 5 years
Residual aortic regurgitation ≤ mild
Presence of none/trace or mild residual aortic regurgitation as assessed by echocardiography during follow-up.
Time frame: 30 days, 1 year, 3 years and 5 years
Six-minute walk test
Change in functional exercise capacity measured by the distance walked during the standardized six-minute walk test (6MWT).
Time frame: 30 days, 1 year, 3 years and 5 years
Evidence of bioprosthetic valve dysfunction and bioprosthetic valve failure
Occurrence of bioprosthetic valve dysfunction or bioprosthetic valve failure as assessed according to established VARC-3 criteria during the follow-up period.
Time frame: 1 year, 3 year and 5 year
Bioprosthetic valve deterioration
Occurrence of bioprosthetic valve deterioration, including structural valve deterioration, as assessed according to established VARC-3 criteria during the follow-up period.
Time frame: 1 year
Length of index hospital stay
Number of days spent in hospital
Time frame: From procedure up to discharge, assessed until 2-3 days post procedure
Improved KCCQ from baseline
This is a Quality of Life questionnaire which includes Kansas City Cardiomyopathy Questionnaire (KCCQ), where usually improvement from baseline is calculated , not simply the absolute score. Higher KCCQ score means better quality of life and Lower KCCQ score means lower quality of life
Time frame: 30 days, 1 year, 3 years and 5 years
Improved EQ-5D from baseline
The EQ-5D (EuroQol 5-Dimension questionnaire) is another standard patient-reported outcome (PRO) used in TAVI studies. This is a generic health-related quality of life (HRQoL) instrument that allows comparisons across different diseases and is frequently used for health economic analyses. Similar to that KCCQ, here as well higher the score, better the quality of life and vice versa for lower score.
Time frame: 30 days, 1 year, 3 years and 5 years
Improved valve function
Percentage of patients with none/trace, mild, or less aortic regurgitation on echocardiographic assessment during follow-up (responder analysis).
Time frame: 30 days, 1 year, 3 years and 5 years
Technical success at exit from procedure
Successful implantation and function of the study device without procedural mortality, need for surgery or intervention related to the device, or device malfunction at exit from the procedure, as defined by VARC-3 criteria.
Time frame: 30 days
Device Success
Successful implantation and intended performance of the study device without procedural mortality, as assessed according to VARC-3 criteria.
Time frame: 30 days
No study locations are listed for this record.
Plan to share: No
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 44 interventional studies with no phase under Aortic Valve Insufficiency, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 74. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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