Clinical trial NCT06049654: Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Official title: Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Structural Valve Deterioration
Keywords: Valve-In-Valve
Aortic stenosis
Aortic regurgitation
Trans-catheter aortic valve
Degenerated aortic valve
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patients meeting ALL the following criteria will be included:

* 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.
* Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.

Exclusion Criteria:

Patients meeting, at least, 1 of the following criteria will be excluded:

* 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.
* Ongoing sepsis and/or suspicious or diagnosis of endocarditis.
* Patients whose life expectancy is \< 1 year due to non-cardiac comorbid conditions.
* Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams.
* True inner diameter of the prosthetic valve \> 27 mm.
* Transfemoral access inadequate to accommodate an 18F sheath.
* Patients included in other clinical trials (excluding registries).

Primary outcomes:
measure: Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).
timeFrame: 30 days
Secondary outcomes:
measure: Proportion of patients with device success after the Valve In Valve (VIV) procedure
timeFrame: 30 days
measure: Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure
timeFrame: 30 days
measure: Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.
timeFrame: 30 days
measure: Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria
timeFrame: 30 days
measure: Clinical efficacy at 1 year as defined by VARC-3 criteria
timeFrame: 1 year
measure: Trans-aortic mean gradient
timeFrame: 1 year
measure: Death
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta De Hierro
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitari I Politècnic de La Fe
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
Study officials:
References:
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