The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.
In the VIVALL.2 study, 104 patients with severely degenerated biological aortic surgical valve accepted for vave-in-valve procedure (transcatheter aortic valve implantation) will be randomized to be treated with the self-expandable supra-annular Allegra or the balloon-expandable intra-annular Edwards systems. The primary end-point will be trans-aortic mean gradient determined by trans-thoracic echocardiography at 30 days. The proportion of patients with moderate or severe prosthesis mismatch at 30 days will be a secondary end-.point. Different countries will participate in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Transcatheter aortic valve implantation of a NVT ALLEGRA TAVI System TF in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
RECRUITINGHospital Clinico San Carlos
Madrid, Spain
RECRUITINGHospital Universitario de La Paz
Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).
Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).
Time frame: 30 days
Proportion of patients with device success after the Valve In Valve (VIV) procedure
Device success after the VIV procedure to the VARC-3 criteria
Time frame: 30 days
Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure
Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure
Time frame: 30 days
Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.
Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.
Time frame: 30 days
Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria
freedom from: all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device.
Time frame: 30 days
Clinical efficacy at 1 year as defined by VARC-3 criteria
freedom from: all-cause mortality, all stroke, hospitalization for procedure- or valve related causes, KCCQ Overall Summary Score \<45 or decline from baseline of \>10 point.
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Madrid, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Spain
RECRUITINGHospital Clínico Universitario de Salamanca
Salamanca, Spain
RECRUITINGHospital Universitari I Politècnic de La Fe
Valencia, Spain
RECRUITINGManchester University NHS Foundation Trust
Manchester, United Kingdom
RECRUITINGFreeman Hospital
Newcastle, United Kingdom
RECRUITINGMorriston Hospital, Swansea
Swansea, United Kingdom
RECRUITINGTime frame: 1 year
Trans-aortic mean gradient
Trans-aortic mean gradient 1 year after TAVR procedure
Time frame: 1 year
Death
Incidence of Death
Time frame: 1 year
Stroke
Incidence of Stroke
Time frame: 1 year