AORTIC VALVE DISEASESREVIVALNCT07524595
Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.
A study testing Hydra THV Series and Sapien THV Series and MyVal THV Series in people with AORTIC VALVE DISEASES and Valve-in-valve Procedures, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AORTIC VALVE DISEASES, Valve-in-valve Procedures, Surgical Valve Replacement
- What is being tested?
- Hydra THV Series and Sapien THV Series and MyVal THV Series
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
"Inclusion Criteria":
- Male or Female patient ≥18 years of age
- Severe hemodynamic valve deterioration of a surgically implanted bioprosthetic aortic valve, including severe valve stenosis and/or severe valve regurgitation, as determined by the Heart Team assessment
- Patients eligible for transfemoral TAVI with both study THV platforms per heart team consensus.
- TAVI (with or without fracture of surgical valve) is suitable with commercially available sizes of both Hydra and Sapien/Myvall BEVs.
- Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee and is willing to comply with all protocol-required (follow-up) evaluations.
"Exclusion criteria":
- Patients unwilling to provide an informed consent, or whose legal representative object to their participation in the study
- Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in woman of child-bearing potential according to local practice)
- Patients with non-transfemoral TAVI access.
- Surgical or transcatheter valve in mitral position (mitral rings are not an exclusion)
- Patients who had received the Bentall procedure.
- Patients with active bacterial endocarditis or ongoing sepsis ≤6 months prior to the index procedure
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Acute myocardial infarction ≤30 days before the intended TAVI procedure
- Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
- Patients with severe left ventricular dysfunction and ejection fraction <30% or hemodynamic instability requiring inotropic agent or mechanical support.
- Patients with significant renal insufficiency (serum creatinine >3.0 mg/dL (265.5μmol/L)) and/or end stage renal disease requiring chronic dialysis
- Patients who are at very high risk of coronary obstruction (e.g., VIVID classification IIB, IIIB, IIIC) and are judged by the heart team to require upfront leaflet laceration (e.g. Basilica or Unicorn procedure) or chimney or snorkel stenting as part of the TAVI procedure.
- Any planned surgical or peripheral procedure to be performed in next 30-day after the index procedure
- Life expectancy <12 months due to non-cardiac co-morbid conditions including carcinomas, chronic liver disease, chronic renal disease or chronic end-stage pulmonary disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site
University of Galway
Galway
Patrick W Serruys, MD, PhD, 353 (0)91 524411 ·, CORRIB.Corelab@universityofgalway.ie
About this study
Official title: Randomised Comparison of Self-Expanding Hydra THV Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis: REVIVAL Trial
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).
- Conditions
- AORTIC VALVE DISEASES, Valve-in-valve Procedures, Surgical Valve Replacement, Valve Disease, Aortic
- Being tested
- Hydra THV Series, Sapien THV Series and MyVal THV Series
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydra THV SeriesDevice
Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Hydra THV Series
Sapien THV Series and MyVal THV SeriesDevice
Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Sapien THV Series and MyVal THV Series
| Study group | Role | What they receive |
|---|---|---|
| Hydra THV Series | Experimental | Self-expanding THV Receives: Device: Hydra THV Series |
| Sapien THV Series, MyVal THV Series | Active comparator | Balloon-expandable THV Receives: Device: Sapien THV Series and MyVal THV Series |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Days
Secondary outcomes (12)
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).
Measured: 30 Days
Post-TAVI invasive mean aortic pressure gradient
Measured: 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)
Measured: 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
Measured: 30 days
Myocardial Infarction rate
Measured: pre-discharge and 30 days
Rate of moderate or severe prosthetic valve regurgitation
Measured: pre-discharge and 30 days
Rate of new conduction abnormalities
Measured: pre-discharge and 30 days
Rate of new permanent pacemaker implantation due to procedure-related conduction abnormalities
Measured: pre-discharge and 30 days
Rate of coronary artery obstruction requiring intervention
Measured: 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)]
Measured: pre-discharge and 30 days
New York Heart Association (NYHA) Functional Classification
Measured: pre-procedure , 30 days
Quality-of-life, Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: pre-procedure, and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AORTIC VALVE DISEASESStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Serruys, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524595
- Sponsor's protocol ID
- UNI-2026-001
- Acronym
- REVIVAL
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Comparison of Self-Expanding Hydra THV Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis: REVIVAL Trial
- ClinicalTrials.gov ID
- NCT07524595
- Acronym / sponsor ID
- REVIVAL / UNI-2026-001
- Conditions
- AORTIC VALVE DISEASES, Valve-in-valve Procedures, Surgical Valve Replacement, Valve Disease, Aortic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydra THV Series | Experimental | Device: Hydra THV SeriesSelf-expanding THV |
| Sapien THV Series, MyVal THV Series | Active comparator | Device: Sapien THV Series and MyVal THV SeriesBalloon-expandable THV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydra THV SeriesTranscatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Hydra THV Series | Device | Hydra THV Series |
| Sapien THV Series and MyVal THV SeriesTranscatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Sapien THV Series and MyVal THV Series | Device | Sapien THV Series, MyVal THV Series |
Primary outcome
Mean pressure gradient across the aortic valve.
Time frame: 30 Days
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.
12 secondary outcomes
Incidence of Moderate/Severe Prosthesis-Patient Mismatch (PPM)
Time frame: 30 Days
Post-TAVI invasive mean aortic pressure gradient
Time frame: 30 Days
Incidence of VARC-3 Device Success rate
Time frame: 30 Days
Freedom from Early safety composite endpoint (rate at 30 days)
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydra THV Series and Sapien THV Series and MyVal THV Series in people with AORTIC VALVE DISEASES and Valve-in-valve Procedures, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pressure gradient across the aortic valve. (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.