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

Aortic Stenosis Clinical Trial

— SOLVE-TAVI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02737150
• Other study ID #: 15-292
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: April 2021

Study information

• Verified date: February 2021
• Source: Leipzig Heart Institute GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 444
• Est. completion date: April 2021
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• CoreValve Evolut R

• Edwards Sapien 3

Procedure:
• Local anesthesia with conscious sedation

• General anesthesia

Locations

Country	Name	City	State
Germany	University of Luebeck	Luebeck

Sponsors (8)

Lead Sponsor	Collaborator
Leipzig Heart Institute GmbH	Charite University, Berlin, Germany, Heart Center Leipzig - University Hospital, Klinikum Links der Weser Bremen, University Hospital Schleswig-Holstein, Campus Kiel, University of Giessen, University of Rostock, University of Schleswig-Holstein, Campus Lübeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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