TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3 (DIRECTAVI)

University Hospital Center (CHU)

Status

Completed

Conditions

Aortic Valve Stenosis

Treatments

Procedure: TAVI

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02729519

2015-A01823-46 (Other Identifier)

RECHMPL15_0392

Details and patient eligibility

About

Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.

Full description

Background Transcatheter aortic valve implantation (TAVI) is now the standard of care for inoperable patients with severe symptomatic aortic stenosis and an accepted alternative to surgery for high-risk patients. Despite a high procedure success rate (> 95%), TAVI remained associated with complications directly related to the technique (stroke, aortic regurgitation, vascular access bleeding) or to co morbidities frequently associated with aortic valve disease in elderly and frail patients. Reducing periprocedural complications is thereby the key for the future use of TAVI in lower-risk patients.

Methods/design The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that include 240 patients randomized to TAVI performed with prior balloon dilatation of the valve (control arm) or direct implantation of the valve (test arm). The trial tests the hypothesis that the strategy of direct implantation of the balloon expandable SAPIEN 3 prosthesis is non-inferior to current medical practice using predilatation of the valve. The primary endpoint is related to immediate procedural success criteria and secondary end points include complications at 30-day follow-up (VARC 2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and after the procedure.

In conclusion, we hope that the study will provide robust evidence of safety and efficiency of TAVI performed without prior dilatation of the aortic valve using the balloon expandable SAPIEN 3 THV and will allow the interventional cardiologist to use this strategy in everyday practice.

Enrollment

250 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Symptomatic Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)
Males or females of at least 18 years of age
Logistic EuroSCORE ≥15% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD) or all patients considered as having excessive surgical risk by the heart team
Signed informed consent
TAVI performed via transfemoral, sub clavicular or transaortic route with the SAPIEN 3 THV (Edwards Lifescience)

Exclusion criteria

Transapical TAVI
Preexisting aortic prosthesis (valve in valve technique)
Vascular conditions that make insertion and endovascular access to the aortic valve impossible
BAV performed for less than one week
Recent myocardial infarction (STEMI within the last 3 months)
Left ventricular or atrial thrombus by echocardiography
Mitral or tricuspidal valvular insufficiency (> grade II)
Evolutive or recent cerebrovascular event (within the last 3 months)
Symptomatic carotid or vertebral arterial narrowing (>70%) disease
Bleeding diathesis or coagulopathy or patient refusing blood transfusion
Lack of written informed consent, severe mental disorder, drug/alcohol addiction
Life expectancy < 1 year
Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media that cannot be adequately premedicated
Participation in another drug or device study that would jeopardize the appropriate analysis of end-points of this study.
High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
Pregnancy