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โ† Trials
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Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort

RecruitingPhase 2Ages 18 Years - anyAllUniversity Hospital, Brest
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In plain words

What the trial is, and whether it could suit you

Aortic valve stenosis is the most common valve disease leading to surgical or percutaneous intervention in Europe and North America. Percutaneous aortic valve replacement (TAVI) is currently recommended for the management of patients with symptomatic aortic stenosis and with high; very high operative risk of aortic valve replacement surgery or intermediate operative risk of aortic valve replacement surgery after a benefit-risk assessment by a heart team and operative contraindication to conventional aortic valve replacement surgery. These indications are supported by the 2017 European Cardiology guidelines. This technique of percutaneous arterial valve implantation is most often performed via the femoral route, under local anesthesia, with placement of a prosthetic biological valve in the aortic position, impacting it into the patient's native aortic valve. TAVI has been shown to be su

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Major patient (\>18 years of age); * Patient with aortic stenosis defined by aortic valve area โ‰ค 1cm2 (or indexed aortic valve area โ‰ค 0.6 cm2/m2 body surface area), OR transvalvular peak velocity โ‰ฅ 4 m/s OR transvalvular mean gradient โ‰ฅ 40 mmHg, as assessed by transthoracic echocardiography performed in a patient at rest; * Symptomatic patient with: dyspnea โ‰ฅ New-York Heart Association (NYHA) stage 2 OR pathological stress test with onset of symptoms on exertion, blood pressure drop, or rhythm disorder on exertion OR Asymptomatic with Left Ventricular Ejection Fraction \< 50% ; * Patient with vascular anatomy compatible with percutaneous femoral valve implantation; * Patient affiliated to or benefiting from a health insurance plan; * Patient who has provided free, informed and written consent. Exclusion Criteria: * Patient with a pacemaker or triple chamber defibrillator prior to TAVI implantation; * Patient with a uni or bicuspid aortic valve; * Patient with severe left ventricular dysfunction LVEF \< 30%; * Patient with other significant valve disease : aortic insufficiency โ‰ฅ grade 3, mitral insufficiency โ‰ฅ grade 3 or tight mitral stenosis ; * Patient with iliofemoral vascular anatomy preventing safe passage of the valve; * Patient with a pre-existing bioprosthesis or mechanical prosthesis at TAVI in any position; * Inability or refusal to consent; * Pregnant or breastfeeding woman; * Patient under judicial protection or family habilitation; * Patient deprived of liberty by judicial or administrative decision, under guardianship or curatorship; * Patient with life expectancy \< 12 months.
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What it tests

  • 18F-FDG PET-CT
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Where

1 site
CHU de Brest
Brest, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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