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

Study Overview
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Brief Summary
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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.

Official Title
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CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: CoreValve Evolut R
* Device: Edwards Sapien 3
* Procedure: Local anesthesia with conscious sedation
* Procedure: General anesthesia


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-expandable valve under local anesthesia<br>CoreValve Evolut R valve under local anesthesia with conscious sedation | Device: CoreValve Evolut R<br> <br> Procedure: Local anesthesia with conscious sedation<br> <br> |
| Active Comparator: Self-expandable valve under general anesthesia<br>CoreValve Evolut R valve under general anesthesia | Device: CoreValve Evolut R<br> <br> Procedure: General anesthesia<br> <br> |
| Active Comparator: Balloon-expandable valve under local anesthesia<br>Edwards Sapien 3 valve under local anesthesia with conscious sedation | Device: Edwards Sapien 3<br> <br> Procedure: Local anesthesia with conscious sedation<br> <br> |
| Active Comparator: Balloon-expandable valve under general anesthesia<br>Edwards Sapien 3 valve under under general anesthesia | Device: Edwards Sapien 3<br> <br> Procedure: General anesthesia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 30 day follow-up |