Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities (NCT04663334) | Clinical Trial Compass
CompletedNot Applicable
Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
France29 participantsStarted 2020-12-08
Plain-language summary
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis.
Severe aortic stenosis is the most common indication of valvular replacement in developed countries. Stable coronary artery disease (CAD) is frequently associated with severe aortic stenosis in patients treated by Transcatheter Aortic Valvular Implantation (TAVI). Its prognostic impact is not clearly established, and available studies uncommonly used functional assessment of severity from a coronary stenosis to stratify the risk in this situation.
Fractional Flow Reserve (FFR) is recommended to guide revascularization by percutaneous coronary intervention (PCI) in clinical practice. Its use is not validated in patients with severe aortic stenosis. Left ventricular hypertrophy induced by aortic obstruction leading to microvascular disorders, and can alter coronary reserve, possibly biasing FFR values. After aortic valvular replacement, a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment.
The aim of the study is to assess the effects of inverse myocardial remodeling on coronary microcirculatory function and its association with FFR values before and after TAVI.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults older than 18 years. For female of childbearing age, active contraceptive method is recommended.
* patients with severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient \>40 mmHg and/or valve area \<1 cm2) and with significant coronary artery disease (epicardial coronary stenosis angiography \> or = to 50%)
Exclusion Criteria:
* Severe CAD with tritroncular lesions or severe stenosis (\>90 %) of left main artery or proximal left anterior descending artery
* Lack of viability in myocardial territory of interest
* History of bypass coronary surgery or heart transplantation
* Severe left ventricular systolic dysfunction, characterized by an ejection fraction \< 35 %
* Severe renal impairment (Creatinine clearance \<30 ml/min/1.73 m2)
* Absolute contraindication to intravenous adenosin
* Pregnant or nursing women Patients under guardianship, curatorship, or protection of justice
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study the change in FFR values before and 6 months after TAVI