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New treatment option for Aortic Valve Stenosis
Official title Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort
ClinicalTrials.gov ID: NCT05308888
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Major patient (\>18 years of age);
- Patient with aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR transvalvular peak...
- Symptomatic patient with: dyspnea ≥ New-York Heart Association (NYHA) stage 2 OR pathological stress test with onset of symptoms on exertion, blood...
- Patient with vascular anatomy compatible with percutaneous femoral valve implantation;
- Patient affiliated to or benefiting from a health insurance plan;
You likely can't join if
- 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 ≥ grade 3, mitral insufficiency ≥ 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;
See the full eligibility criteria
- Major patient (\>18 years of age);
- Patient with aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2/m2 body surface area), OR transvalvular peak velocity ≥ 4 m/s OR transvalvular mean gradient ≥ 40 mmHg, as...
- Symptomatic patient with: dyspnea ≥ 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...
- 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.
- 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 ≥ grade 3, mitral insufficiency ≥ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.