SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI

Helios Health Institute GmbH444 enrolled

Overview

Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

444

Conditions

Aortic Stenosis

Interventions

CoreValve Evolut RDEVICE

Edwards Sapien 3DEVICE

Local anesthesia with conscious sedationPROCEDURE

General anesthesiaPROCEDURE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m² * Age ≥75 years and/or logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% and/or Society of Thoracic Surgeons (STS) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement * Native aortic valve annulus measuring 18-29 mm * Suitability for transfemoral vascular access * Written informed consent Exclusion Criteria: * Life expectancy \<12 months due to comorbidities * Cardiogenic shock or hemodynamic instability * History of or active endocarditis * Contraindications for transfemoral access * Active peptic ulcer or upper gastro-intestinal bleeding \<3 months * Hypersensitivity or contraindication to aspirin, heparin or clopidogrel * Contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the Heart Team * Active infection requiring antibiotic treatment * Participation in another trial

Locations (1)

University of Luebeck

Lübeck, Germany

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events (Device)

Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation

Time frame: 30 day follow-up

Incidence of Treatment-Emergent Adverse Events (Anesthesia)

Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury

Time frame: 30 day follow-up

Data from ClinicalTrials.gov

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