Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 18 years.
Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area < 1.0 cm2) and/or severe valve regurgitation.
The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease.
Heart team decision of VIV procedure.
Disqualifiers
Patients who openly express their refusal to participate in the study.
Female patients in gestational age.
Presence or suspicious of biological aortic valve thrombosis.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NVT ALLEGRA TAVI System TF
DeviceTranscatheter aortic valve implantation of a NVT ALLEGRA TAVI System TF in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
DeviceTranscatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: NVT ALLEGRA System TFActive comparator 1 intervention
Group B: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 days2
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 days3
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 days4
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 daysSponsors and contacts
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Source ClinicalTrials.gov