ACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems

2019-11-11 17:49:15 | BioPortfolio


A Multicenter, prospective, non-randomized, non-inferiority trial evaluating the safety and clinical efficacy of the next-generation, self-expandable Boston Scientific ACURATE NEO/TF Transcatheter Heart Valves, implanted in patients with severe aortic stenosis. A comparison with the Medtronic EVOLUT R/EVOLUT PRO systems from DIRECT trial.


The aim of this study is to evaluate the 30 day clinical and echo outcomes of Boston Scientific ACURATE NEO/TF TAVR and to compare them with outcomes in patients from the DIRECT trial treated with the Evolut TAVR system (Evolut R and Evolut PRO), aiming in showing non-inferiority of the ACURATE NEO/TF device. Primary endpoint will be device success rate as defined by the VARC-2 criteria. Secondary endpoints involve the composite endpoint of early safety at 30 days, according to the VARC-2 definitions, specifically all cause mortality, cardiovascular mortality, stroke-TIA, acute kidney injury, conduction disturbances-arrhythmias, life-threatening or disabling bleeding, myocardial infarction, major vascular complication, valve related dysfunction requiring repeat procedure (BAV,TAVR,SAVR) as well as the echocardiographic outcomes and valve performance as designated by the VARC-2 definitions at 30 days.

Study type: Observational, non-inferiority trial

Estimated Enrollment: 80 patients

Allocation: Non - randomized, all comers

Primary Purpose: Treatment

Observational Model: Case-Control

Condition or disease: Aortic valve stenosis

Intervention/Treatment: Device: Boston Scientific ACURATE neoTM transfemoral TAVI system

Time Perspective: Prospective

Participating centers: Henry Dunant Hospital (Athens, Greece), Hippokration Hospital (Athens, Greece), Silesian Center for Heart Diseases (Zabrze, Poland), Athens Naval Hospital (Athens, Greece). It is possible that the number of the participating center may change.

Methods: Based on an anticipated incidence proportion of 90% for the primary composite endpoint of device success at 30 days, the total required sample size amounts to 80 patients. Patients treated with the Boston Scientific ACURATE NEO/TF system will be prospectively. All patients will be followed for at least 30 days. Event rates will be presented by Kaplan-Meier curves. On the basis of previous observations regarding TAVR success rate by VARC 2 definitions (DIRECT study), the study design uses a predefined non-inferiority margin of Δ = 15% for the primary endpoint of device success rate at 30 days. The primary hypothesis is non-inferiority of ACURATE NEO/TF TAVR versus Evolut R and Evolut-Pro TAVR (based on the results of the DIRECT trial) for the primary endpoint at 30 days. The non-inferiority assumption will be tested at a one-sided significance level with a type I error rate (a=0.05). Non-inferiority will be met if the lower bound of the one-sided 95% confidence interval (CI) of the primary weighted difference of proportions endpoint (weighted average test-control) is over -15%. Pre-specified subgroup analyses will be conducted by using the appropriate interaction tests contrasting categories of mean gradient, aortic valve area (AVA) and left ventricular ejection fraction (>50% vs 50%).

Study Design


Aortic Stenosis


Transcatheter Aortic Valve Implantation with ACURATE NEO/TF, Transcatheter Aortic Valve Implantation with Medtronic Evolut R/Pro


Hippocration Hospital First Department of Cardiology, University of Athens, Medical School




National and Kapodistrian University of Athens

Results (where available)

View Results


Published on BioPortfolio: 2019-11-11T17:49:15-0500

Clinical Trials [1742 Associated Clinical Trials listed on BioPortfolio]

Mini-invasive Balloon Aortic Valvuloplasty

The spreading of transcatheter aortic valve implantation has paradoxically increased the spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is currently...

Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.

Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve repla...

TriGuard Embolic Deflection Device to Reduced Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

The Keystone Heart TriGuard™ device is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteri...

Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement

Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve repla...

POLESTAR Trial - An International Multi-center Early Discharge TAVI Program

An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are e...

PubMed Articles [2523 Associated PubMed Articles listed on BioPortfolio]

Pulsatile sterile abscess in the left breast following transapical transcatheter aortic valve implantation: a case report.

Over the last decade, transcatheter treatment of degenerative aortic valve stenosis has been established as an alternative to surgical aortic valve replacement. Late complications of transcatheter tre...

Transaortic Transcatheter Aortic Valve Implantation: Learning Curve, Perioperative, and Midterm Follow-Up Results of a Single Center.

We present our initial institutional experience with transaortic (TAo) transcatheter aortic valve implantation (TAVI) using a self-expanding aortic bioprosthesis.

Endovascular Repair of Ruptured Ascending Aorta Secondary to Embolized Transcatheter Aortic Valve.

Since its approval by the U.S. Food and Drug Administration in 2011, transcatheter aortic valve replacement has revolutionized the treatment of aortic valvular disease with a rapid increase in utiliza...

Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis.

Owing to new evidence from randomized controlled trials (RCTs) in low-risk patients with severe aortic stenosis, we compared the collective safety and efficacy of transcatheter aortic valve implantati...

Minimalistic Approach for Transcatheter Aortic Valve Implantation (TAVI): Open Vascular Vs. Fully Percutaneous Approach.

Aortic stenosis (AS) is the most common valvular heart disease in elderly people. Transcatheter aortic valve implantation (TAVI) has emerged as a revolutionary treatment for elderly patients with symp...

Medical and Biotech [MESH] Definitions

Surgical treatment for severe AORTIC VALVE STENOSIS. Transcatheter aortic valve replacement (TAVR) is used as an alternative option in patients who are deemed at high risk or inoperable for traditional open-heart surgery.

The downward displacement of the cuspal or pointed end of the trileaflet AORTIC VALVE causing misalignment of the cusps. Severe valve distortion can cause leakage and allow the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to aortic regurgitation.

Pathological condition characterized by the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to regurgitation. It is caused by diseases of the AORTIC VALVE or its surrounding tissue (aortic root).

A type of constriction that is caused by the presence of a fibrous ring (discrete type) below the AORTIC VALVE, anywhere between the aortic valve and the MITRAL VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.

A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.

More From BioPortfolio on "ACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems"

Quick Search

Relevant Topics

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...

Searches Linking to this Trial