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.

NCT07524595 | Not Yet Recruiting DMC

• 1 other identifier: UNI-2026-001
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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. 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; Surgical Valve Replacement; Valve-in-valve Procedures; Valve Disease, Aortic

Outcome Measures

Primary Outcomes (1)

• 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.

  30 Days

Secondary Outcomes (12)

• Incidence of Moderate/Severe Prosthesis-Patient Mismatch (PPM)

  30 Days

• Post-TAVI invasive mean aortic pressure gradient

  30 Days

• Incidence of VARC-3 Device Success rate

  30 Days

• Freedom from Early safety composite endpoint (rate at 30 days)

  30 days

• Myocardial Infarction rate

  pre-discharge and 30 days

Study Arms (2)

Hydra THV Series

EXPERIMENTAL

Self-expanding THV

Device: Hydra THV Series

Sapien THV Series, MyVal THV Series

ACTIVE COMPARATOR

Balloon-expandable THV

Device: Sapien THV Series and MyVal THV Series

Interventions

Hydra THV Series DEVICE

Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Hydra THV Series

Hydra THV Series

Sapien THV Series and MyVal THV Series DEVICE

Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Sapien THV Series and MyVal THV Series

Sapien THV Series, MyVal THV Series

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (1)

University of Galway

Galway, Ireland

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IE (1)