Clinical trial NCT04157920: Impact of Predilatation Between Self-expanding Valves
Official title: Impact of Balloon Predilatation Between Self-expanding Valves in All Comers Undergoing TAVI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: Aortic stenosis
DIRECT
ACURATE
TAVI
TAVR
transcatheter
valve
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Naval Hospital, Athens
name: Silesian Centre for Heart Diseases
name: University General Hospital of Heraklion
name: Interbalkan Medical Center, Thessaloniki, Greece
First posted: 2019-11-08
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing TAVR for severe aortic stenosis with two different transcatheter devices. One arm received Medtronic Evolut R/Pro. The other is receiving Boston Scientific ACURATE NEO/TF
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Device success
timeFrame: 30 days
Secondary outcomes:
measure: All cause Mortality
timeFrame: 30 days
measure: All stroke
timeFrame: 30 days
measure: New pacemaker implantation
timeFrame: 30 days
measure: Major Vascular complications
timeFrame: 30 days
measure: Echocardiographic endpoint
timeFrame: 30 days
measure: Post-dilatation
timeFrame: 30 days
measure: Major Bleeding
timeFrame: 30 days
measure: Acute kidney injury stage 2 or 3
timeFrame: 30 days
measure: Device success
timeFrame: 30 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hippocration Hospital First Department of Cardiology, University of Athens, Medical School
Study officials:
affiliation: Professor of Cardiology
name: Konstantinos P Toutouzas, Professor
role: STUDY_DIRECTOR
References:
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