Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II: A Randomized, Controlled, Non-inferiority Trial Evaluating Safety and Clinical Efficacy of the Symetis ACURATE Neo Compared to the Medtronic Evolut R Bioprosthesis in Transfemoral Transcatheter Aortic Valve Implantation

Ceric Sàrl23 sites in 6 countries796 target enrollmentApril 20, 2017

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Ceric Sàrl
Enrollment: 796
Locations: 23
Primary Endpoint: Composite of all-cause mortality or stroke rates
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).

Detailed Description

Transcatheter aortic valve implantation (TAVI) is an established and valuable treatment option for patients with severe symptomatic aortic stenosis and at high surgical risk for aortic valve replacement. The use of TAVI is rapidly expanding worldwide and its indications are widening into intermediate and lower risk populations. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves. The Symetis ACURATE neo™, a self-expanding transcatheter valve delivered via transfemoral access, is a second-generation device that gained CE mark approval in June 2014. The SCOPE-II trial will compare the safety and performance of the Symetis ACURATE neo™ with the self-expanding Medtronic Evolut R system, a widely used and well-established transcatheter heart valve, which obtained CE mark in 8NOV2006 and HAS approval on 13JAN2015.

Registry

clinicaltrials.gov

Start Date

April 20, 2017

End Date

June 4, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ceric Sàrl

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient with severe symptomatic aortic stenosis defined by a mean aortic gradient \> 40 mmHg or peak jet velocity \> 4.0 m/s or an aortic valve area (AVA) \< 1cm2 or AVA indexed to body surface area (BSA) of \<0.6 cm2/m2
•Patient is symptomatic (heart failure with New York Heart Association (NYHA) Functional Class \> I, angina or syncope)
•Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of a cardiologist and surgeon or as confirmed by a logistic EuroSCORE I \> 20% and / or STS score \> 10%.
•Aortic annulus diameter ranging from 21 to 26mm and perimeter rage from 66 - 81.7mm , based on ECG-gated multi-slice computed tomographic measurements. Findings of TTE, TEE and conventional aortography should be integrated in the anatomic assessment.
•Arterial aorto-iliac-femoral axis suitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter ≥ 6mm)
•Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up
•Patient age 75 years or older
•Patient has given written consent to participate in the trial

Exclusion Criteria

•Severely reduced left ventricular (LV) function (ejection fraction \<20%)
•Pre-existing prosthetic heart valve in aortic and/or mitral position
•Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol
•Severe coagulation conditions
•Inability to tolerate anticoagulation therapy
•Contraindication to contrast media or allergy to nitinol
•Active infection, including endocarditis
•Congenital aortic stenosis or unicuspid or bicuspid aortic valve
•Non-valvular aortic stenosis
•Hypertrophic obstructive cardiomyopathy

Outcomes

Primary Outcomes

Composite of all-cause mortality or stroke rates

Time Frame: 1 year

The primary objective is to compare the composite of all-cause mortality or stroke rates at 1 year (powered for non-inferiority).

Secondary Outcomes

Annular rupture/dissection at 30 days(30 days)
Left ventricular perforation at 30 days(30 days)
Stroke at 30 days(30 days)
Cardiac Tamponade at 30 days(30 days)
Valve malpositioning at 30 days(30 days)
Implantation of multiple valves (TAV-in-TAV deployment) at 30 days(30 days)
Conversion to open heart surgery at 30 days(30 days)
Intra-procedural mortality (during index procedure)(Procedurally)
New permanent pacemaker rate(30 days)
Peri-procedural myocardial infarction at 30 days(30 days)
All cause mortality at 30 days(30 days)
Myocardial infarction at 30 days and 1 year(30 days and 1 year)
Endocarditis at 30 days and 1 year(30 days and 1 year)
New pacemaker implantation at 1 year(1 year)
Any arrhythmia resulting in hemodynamic instability or requiring therapy at 30 days and 1 year(30 days and 1 year)
Echocardiographic endpoint (2)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Echocardiographic endpoint (3)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Echocardiographic endpoint (4)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Composite of all-cause mortality or disabling stroke at 30 days and 1 year(30 days and 1 year)
Valve related dysfunction requiring repeat procedure at 30 days and 1 year(30 days and 1 year)
Echocardiographic endpoint (7)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Echocardiographic endpoint (9)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Procedural mortality (up to 72 hours after procedure)(Procedurally and up to 72 hours post-procedurally)
All stroke (disabling/non disabling) at 30 days and 1 year(30 days and 1 year)
Life-threatening/major bleeding at 30 days and 1 year(30 days and 1 year)
Echocardiographic endpoint (10)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Mortality (cardiac/non-cardiac) at 30 days and 1 year(30 days and 1 year)
New AV-conduction disturbances at 30 days and 1 year(30 days and 1 year)
Echocardiographic endpoint (11)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Hospitalization for valve-related symptoms or worsened congestive heart at 30 days and 1 year(30 days and 1 year)
Valve thrombosis at 30 days and 1 year(30 days and 1 year)
VARC-2 combined endpoints at 30 days(30 days)
Time-related valve safety at 1 year(1 year)
Echocardiographic endpoint (1)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Echocardiographic endpoint (6)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Echocardiographic endpoint (5)(Post-procedurally [day 1 to 7], at 30 days, 1 year)
Echocardiographic endpoint (8)(Post-procedurally [day 1 to 7], at 30 days, 1 year)