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New treatment option for Severe Aortic Stenosis
Official title CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis
ClinicalTrials.gov ID: NCT07469371
What this study is testing
- What it's testing
- Severe aortic stenosis (AS) is often accompanied by coronary artery disease (CAD). While coronary computed tomography angiography (CCTA) is routinely used before aortic valve replacement (AVR) to evaluate coronary anatomy, it lacks physiological assessment of myocardial ischemia.
- Which group you join is decided by chance.
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
- Age \>18 years.
- Severe aortic stenosis confirmed by echocardiography, defined as peak aortic jet velocity (Vmax) ≥4.0 m/s, mean transvalvular gradient ≥40 mmHg, or...
- New York Heart Association (NYHA) functional class II or higher.
- Eligible for both transfemoral transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).
- Undergoing preoperative coronary computed tomography angiography (CCTA).
You likely can't join if
- Allergy to prosthetic valve materials or iodinated contrast agents.
- Contraindication or allergic reaction to anticoagulants or antiplatelet agents, or inability to tolerate required anticoagulant or antiplatelet...
- Active infective endocarditis or any other active infection.
- Severe vascular disease precluding safe implantation of a prosthetic valve.
- Ascending aortic diameter ≥50 mm.
- Prior prosthetic valve implantation in any cardiac position or prior coronary artery bypass grafting (CABG).
See the full eligibility criteria
- Age \>18 years.
- Severe aortic stenosis confirmed by echocardiography, defined as peak aortic jet velocity (Vmax) ≥4.0 m/s, mean transvalvular gradient ≥40 mmHg, or aortic valve area (AVA) ≤1.0 cm² [or indexed aortic valve area (AVAi)...
- New York Heart Association (NYHA) functional class II or higher.
- Eligible for both transfemoral transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).
- Undergoing preoperative coronary computed tomography angiography (CCTA).
- Willing to participate in the study and able to provide written informed consent.
- Allergy to prosthetic valve materials or iodinated contrast agents.
- Contraindication or allergic reaction to anticoagulants or antiplatelet agents, or inability to tolerate required anticoagulant or antiplatelet therapy.
- Active infective endocarditis or any other active infection.
- Severe vascular disease precluding safe implantation of a prosthetic valve.
- Ascending aortic diameter ≥50 mm.
- Prior prosthetic valve implantation in any cardiac position or prior coronary artery bypass grafting (CABG).
- Preoperative imaging confirming aortic root anatomy unsuitable for transcatheter aortic valve implantation.
- Intracardiac mass, left ventricular or left atrial thrombus, or vegetation confirmed by preoperative echocardiography.
- Acute myocardial infarction within 30 days before surgery.
- Clinically diagnosed stroke or transient ischemic attack within 3 months before surgery.
- Bleeding or coagulation disorders within 3 months before surgery that required hospitalization or blood transfusion or were otherwise clinically significant and would preclude the antiplatelet therapy required in this...
The study team makes the final eligibility decision.
Where it's taking place
- Kunming, Yunnan, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Kunming, Yunnan, China. 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.