Brief Title
Impact of Predilatation Between Self-expanding Valves
Official Title
Impact of Balloon Predilatation Between Self-expanding Valves in All Comers Undergoing TAVI
Brief Summary
A Multicenter, prospective, non-randomized, 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 and the impact of predilatation in
comparison with the Medtronic CoreValve EvolutT R/PRO systems from the DIRECT trial.
Detailed Description
The aim of the present prospective, multicenter, non-randomized trial is to compare the
device success rate and the in-hospital and 30-day safety and echocardiographic clinical
outcomes between TAVI with and without predilatation in all comers undergoing implantation of
self-expanding valves. 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, acute kidney injury, life-threatening or disabling bleeding, major
vascular complication, as well as the echocardiographic outcomes and valve performance as
designated by the VARC-2 definitions at 30 days. VARC-1 and VARC-3 device success rates will
be estimated as well.
Study type: Observational
Estimated Enrollment: 75 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: 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: Patients treated with the Boston Scientific ACURATE NEO/TF system will be
prospectively. All patients will be followed for at least 30 days. A primary study by Pagnesi
et al. estimated the device success rate by ACURATE neo valve at 83% whereas Toutouzas et al.
estimated the device success rate by Medtronic CoreValve/Evolut R/PRO at 76% (6, 17). Taking
83% as our point estimate, the steering committee of DIRECT II considers that ACURATE neo
valve can be regarded as non-inferior to Medtronic CoreValve/Evolut R/PRO if the lower margin
of the confidence interval does not lies under the rate of 83% by more than 5% (i.e. if it is
not lower than 78%). Based on these assumptions, an expected sample size of 65 patients is
required to achieve 80% power to demonstrate the efficacy of ACURATE neo valve, when type I
error rate is set at 0.05. To eliminate possible impact of a small dropout rate, a total of
78 patients were recruited
Study Type
Interventional
Primary Outcome
Device success
Secondary Outcome
All cause Mortality
Condition
Aortic Stenosis
Intervention
Transcatheter Aortic Valve Implantation with ACURATE NEO/TF
Study Arms / Comparison Groups
Patients treated with Medtronic CoreValve/ Evolut R/Pro
Description: TAVI patients treated with Medtronic CoreValve /Evolut R - Evolut PRO Transcatheter Heart Valves, participated in the DIRECT trial
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
78
Start Date
September 17, 2019
Completion Date
December 20, 2021
Primary Completion Date
April 1, 2021
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 EuroSCORE II ≥ 7% STS score ≥
8% OR
- Over 80 years old OR
- Over 65 years old with 1 or 2 (but not more than two) from the following criteria:
Liver cirrhosis (Class A or B). Pulmonary insufficiency: VMS<1 liter. Previous heart
surgery (CABG, vascular surgery). Porcelain aorta. Pulmonary artery systolic pressure >60
mmHg and high risk for heart surgery. Relapsing pulmonary embolism. Right ventricular
insufficiency. Thoracic wall injuries that contraindicate an open heart surgery. History of
radiation therapy of the mediastinum. Connective tissue disease that contraindicates an
open heart surgery. Frailty/cachexia.
- Aortic valve diameter of ≥20mm and ≤2 9mm as measured by echo.
- Ascending aorta diameter ≤ 43 mm at the sinotubular junction.
- 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 has given written consent to participate in the trial
Exclusion Criteria:
- A known hypersensitivity or contraindication to any of the following which cannot be
adequately pre-medicated: aspirin or heparin and bivalirudin, ticlodipine and
clopidogrel, nitinol (titanium or nickel), contrast media
- Ongoing sepsis, including active endocarditis.
- Any percutaneous coronary or peripheral interventional procedure with a bare metal or
drug eluting stent performed within 30 days prior to Heart Team assessment.
- Echocardiographic evidence of LV or LA thrombus.
- Mitral or tricuspid valve insufficiency (> grade II).
- Previous aortic valve replacement (mechanical or bioprosthetic).
- Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or
transient ischemic attack (TIA).
- Patients with:
Femoral, iliac or aortic vascular disease (stenosis etc) that precludes the insertion of a
transcatheter sheath.
OR Symptomatic carotid or vertebral artery disease (> 70% stenosis).
- The patient has a bleeding diathesis, coagulopathy or denies blood transfusion.
- Estimated life expectancy of less than 12 months due to associated non-cardiac
co-morbid conditions.
- Creatinine clearance < 20 ml/min.
- Active gastritis or gastrointestinal ulcer.
- Pregnancy.
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <
20%.
- Unicuspid aortic valve.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation> 2+).
- Liver failure (Child-Pugh class C).
- Severe dementia (resulting in either inability to provide informed consent for the
study/procedure, prevents independent lifestyle outside of a chronic care facility, or
will fundamentally complicate rehabilitation from the procedure or compliance with
follow-up visits).
- Extreme aortic valve calcification and calcific asymmetry (Agatston score: grade 4
AgS>5000 AU).
- Aortic valve area of < 0.4 cm2.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Konstantinos P Toutouzas, Professor, ,
Location Countries
Greece
Location Countries
Greece
Administrative Informations
NCT ID
NCT04157920
Organization ID
DIRECT II
Responsible Party
Principal Investigator
Study Sponsor
National and Kapodistrian University of Athens
Collaborators
Naval Hospital, Athens
Study Sponsor
Konstantinos P Toutouzas, Professor, Study Director, Professor of Cardiology
Verification Date
November 2021