AORTIC VALVE DISEASES, Surgical Valve Replacement, Valve Disease, Aortic, Valve-in-valve Procedures
Conditions
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).
Interventions
DEVICEHydra THV Series
Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Hydra THV Series
DEVICESapien THV Series and MyVal 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
Sponsors
National University of Ireland, Galway, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
"Inclusion Criteria": 1. Male or Female patient ≥18 years of age 2. 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 3. Patients eligible for transfemoral TAVI with both study THV platforms per heart team consensus. 4. TAVI (with or without fracture of surgical valve) is suitable with commercially available sizes of both Hydra and Sapien/Myvall BEVs. 5. 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
": 1. Patients unwilling to provide an informed consent, or whose legal representative object to their participation in the study 2. 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) 3. Patients with non-transfemoral TAVI access. 4. Surgical or transcatheter valve in mitral position (mitral rings are not an exclusion) 5. Patients who had received the Bentall procedure. 6. Patients with active bacterial endocarditis or ongoing sepsis ≤6 months prior to the index procedure 7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation 8. Acute myocardial infarction ≤30 days before the intended TAVI procedure 9. 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 10. Patients with severe left ventricular dysfunction and ejection fraction \<30% or hemodynamic instability requiring inotropic agent or mechanical support. 11. Patients with significant renal insufficiency (serum creatinine \>3.0 mg/dL (265.5μmol/L)) and/or end stage renal disease requiring chronic dialysis 12. 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. 13. Any planned surgical or peripheral procedure to be performed in next 30-day after the index procedure 14. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean pressure gradient across the aortic valve. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Moderate/Severe Prosthesis-Patient Mismatch (PPM) | 30 Days | VARC-3 criteria (iEOA ≤0.85 cm²/m² for BMI \<30 kg/m² or ≤0.70 cm²/m² for BMI ≥30 kg/m²). |
| Post-TAVI invasive mean aortic pressure gradient | 30 Days | — |
| Incidence of VARC-3 Device Success rate | 30 Days | * 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) |
| Freedom from Early safety composite endpoint (rate at 30 days) | 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 |
| Myocardial Infarction rate | pre-discharge and 30 days | — |
| Rate of moderate or severe prosthetic valve regurgitation | pre-discharge and 30 days | — |
| Rate of new conduction abnormalities | pre-discharge and 30 days | — |
| Rate of new permanent pacemaker implantation due to procedure-related conduction abnormalities | pre-discharge and 30 days | — |
| Rate of coronary artery obstruction requiring intervention | pre-discharge | — |
| Echocardiographic endpoints | pre-discharge and 30 days | 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 \[(EOA x Aortic Cross-Sectional Area)/(Aortic Cross-Sectional Area - EOA)\] |
| New York Heart Association (NYHA) Functional Classification | pre-procedure , 30 days | — |
| Quality-of-life, Kansas City Cardiomyopathy Questionnaire (KCCQ) | pre-procedure, and 30 days | — |
Countries
Ireland
Outcome results
None listed