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

Helios Health Institute GmbH

Status: Unknown

Conditions: Aortic Stenosis

Treatments: Procedure: Local anesthesia with conscious sedation; Device: CoreValve Evolut R; Device: Edwards Sapien 3; Procedure: General anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02737150

15-292

Details and patient eligibility

About

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.

Enrollment: 444 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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444 participants in 4 patient groups

Self-expandable valve under local anesthesia

Active Comparator group

Description:

CoreValve Evolut R valve under local anesthesia with conscious sedation

Treatment:

Device: CoreValve Evolut R

Procedure: Local anesthesia with conscious sedation

Self-expandable valve under general anesthesia

Active Comparator group

Description:

CoreValve Evolut R valve under general anesthesia

Treatment:

Device: CoreValve Evolut R

Procedure: General anesthesia

Balloon-expandable valve under local anesthesia

Active Comparator group

Description:

Edwards Sapien 3 valve under local anesthesia with conscious sedation

Treatment:

Procedure: Local anesthesia with conscious sedation

Device: Edwards Sapien 3

Balloon-expandable valve under general anesthesia

Active Comparator group

Description:

Edwards Sapien 3 valve under under general anesthesia

Treatment:

Procedure: General anesthesia

Device: Edwards Sapien 3