An interventional study of Hydra THV Series and Sapien THV Series and MyVal THV Series in AORTIC VALVE DISEASES, Valve-in-valve Procedures and Surgical Valve Replacement, sponsored by National University of Ireland, Galway, Ireland. Not yet recruiting at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by National University of Ireland, Galway, Ireland · Not applicable, Interventional, and Treatment
This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic bioprosthesis. A total of 111 patients will be randomized in a 2:1 ratio, with 74 patients assigned to self-expanding Hydra THV Series and 37 patients assigned to BEV (Sapien THV Series and MyVal THV Series).
234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.
This study's planned enrollment of 111 is close to the median of 111 across 125 interventional studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →National University of Ireland, Galway, Ireland is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
"Inclusion Criteria":
"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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
Self-expanding THV
Device: Hydra THV Series
Balloon-expandable THV
Device: Sapien THV Series and MyVal THV Series
Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Hydra THV Series
Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Sapien THV Series and MyVal THV Series
Mean pressure gradient across the aortic valve.
The objective is to demonstrate that the self-expanding Hydra THV series is non-inferior, and potentially superior, to balloon-expandable valves (Sapien and MyVal THV series) in terms of hemodynamic performance for patients undergoing ViV TAVI for failed surgical aortic bioprostheses.
Time frame: 30 Days
Incidence of Moderate/Severe Prosthesis-Patient Mismatch (PPM)
VARC-3 criteria (iEOA ≤0.85 cm²/m² for BMI \<30 kg/m² or ≤0.70 cm²/m² for BMI ≥30 kg/m²).
Time frame: 30 Days
Post-TAVI invasive mean aortic pressure gradient
Time frame: 30 Days
Incidence of VARC-3 Device Success rate
* Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * VARC3 Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index \>0.25, and less than moderate aortic regurgitation)
Time frame: 30 Days
Freedom from Early safety composite endpoint (rate at 30 days)
freedom from all-cause mortality freedom from all stroke freedom from VARC type 2-4 bleeding freedom from major vascular, access-related, or cardiac structural complication freedom from acute kidney injury stage 3 or 4 freedom from moderate or severe aortic regurgitation freedom from new permanent pacemaker due to procedure-related conduction abnormalities freedom from surgery or intervention related to the device
Time frame: 30 days
Myocardial Infarction rate
Time frame: pre-discharge and 30 days
Rate of moderate or severe prosthetic valve regurgitation
Time frame: pre-discharge and 30 days
Rate of new conduction abnormalities
Time frame: pre-discharge and 30 days
Rate of new permanent pacemaker implantation due to procedure-related conduction abnormalities
Time frame: pre-discharge and 30 days
Rate of coronary artery obstruction requiring intervention
Time frame: pre-discharge
Echocardiographic endpoints
Effective orifice area (EOA) Index effective orifice area (iEOA) Mean aortic valve gradient Peak aortic valve gradient Peak aortic velocity Total aortic regurgitation, transvalvular regurgitation (except baseline) and paravalvular regurgitation (except baseline) Left ventricular ejection fraction (LVEF) Energy lost index (ELI) calculated as \[(EOA x Aortic Cross-Sectional Area)/(Aortic Cross-Sectional Area - EOA)\]
Time frame: pre-discharge and 30 days
New York Heart Association (NYHA) Functional Classification
Time frame: pre-procedure , 30 days
Quality-of-life, Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: pre-procedure, and 30 days
Plan to share: Undecided
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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National University of Ireland, Galway, Ireland