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

Not Applicable

• Conditions: Aortic Stenosis
• Interventions: Device: CoreValve Evolut R; Device: Edwards Sapien 3; Procedure: Local anesthesia with conscious sedation; Procedure: General anesthesia

• Registration Number: NCT02737150
• Lead Sponsor: Helios Health Institute GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-09
• Study First Posted: 2016-04-13
• Primary Completion: 2019-02-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 444

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Self-expandable valve under local anesthesia	CoreValve Evolut R	CoreValve Evolut R valve under local anesthesia with conscious sedation
Balloon-expandable valve under general anesthesia	Edwards Sapien 3	Edwards Sapien 3 valve under under general anesthesia
Self-expandable valve under local anesthesia	Local anesthesia with conscious sedation	CoreValve Evolut R valve under local anesthesia with conscious sedation
Self-expandable valve under general anesthesia	CoreValve Evolut R	CoreValve Evolut R valve under general anesthesia
Balloon-expandable valve under local anesthesia	Local anesthesia with conscious sedation	Edwards Sapien 3 valve under local anesthesia with conscious sedation
Balloon-expandable valve under general anesthesia	General anesthesia	Edwards Sapien 3 valve under under general anesthesia
Self-expandable valve under general anesthesia	General anesthesia	CoreValve Evolut R valve under general anesthesia
Balloon-expandable valve under local anesthesia	Edwards Sapien 3	Edwards Sapien 3 valve under local anesthesia with conscious sedation

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (Anesthesia)	30 day follow-up	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
Incidence of Treatment-Emergent Adverse Events (Device)	30 day follow-up	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

Trial Locations

Locations (1)

University of Luebeck; 🇩🇪 Luebeck, Germany