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New treatment option for Transcatheter Aortic Valve Replacement
Official title Coronary Artery Disease Assessment Strategies in TAVI Patients
ClinicalTrials.gov ID: NCT06559332
What this study is testing
- What it's testing
- Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- Inclusion:
- Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s OR if mean gradient \ 2000...
- Coronary calcium score ≥ 400 Agatston units (derived from routine pre-TAVI CT) or known coronary artery disease
- Selected for treatment with transfemoral TAVI.
- Written informed consent.
You likely can't join if
- Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention
- Unprotected left main coronary stenosis \>50% or left main not evaluable based on coronary computed tomography angiography derived from routine...
- Left ventricular ejection fraction (LVEF) \< 30%
- New regional wall motion abnormalities on echocardiography
- Myocardial infarction in previous 12 months
- Coronary angiography in previous 12 months
See the full eligibility criteria
- Inclusion:
- Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s OR if mean gradient \ 2000 Agatston units in men, \>1200 in women OR if mean gradient \ 2000 Agatston...
- Coronary calcium score ≥ 400 Agatston units (derived from routine pre-TAVI CT) or known coronary artery disease
- Selected for treatment with transfemoral TAVI.
- Written informed consent.
- Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention
- Unprotected left main coronary stenosis \>50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT
- Left ventricular ejection fraction (LVEF) \< 30%
- New regional wall motion abnormalities on echocardiography
- Myocardial infarction in previous 12 months
- Coronary angiography in previous 12 months
- Prior left main stenting
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
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, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland. 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.