Assessing coronary function before and after heart valve replacement in patients with aortic stenosis
Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
This study is testing how a heart valve replacement procedure affects blood flow in the hearts of people with severe aortic stenosis to see if their heart function improves over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helios Health Institute GmbH Academic / other |
| Locations | 1 site (Leipzig) |
| Trial ID | NCT05133843 on ClinicalTrials.gov |
What this trial studies
This study evaluates the complete coronary physiology in patients with severe symptomatic aortic stenosis who are candidates for transcatheter aortic valve implantation (TAVI). It involves measuring various coronary flow metrics, such as fractional flow reserve (FFR) and coronary flow reserve (CFR), both before and six months after the TAVI procedure. The goal is to understand how TAVI impacts coronary blood flow and microcirculatory function over time. Additionally, the study aims to correlate invasive and non-invasive functional testing results to enhance the understanding of coronary artery stenosis in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with severe symptomatic aortic stenosis and intermediate coronary artery stenosis who are eligible for TAVI.
Not a fit: Patients with non-diagnostic CT-angiography results or those who have had previous coronary artery bypass grafting with patent grafts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of coronary artery stenosis in patients undergoing TAVI, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promising results in assessing coronary physiology in similar patient populations, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Willing to participate and able to understand, read and sign the informed consent document before the planned procedure * Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team * Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out * CAD in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis). * Eligible for invasive coronary angiography and functional assessment (FFR, RFR, CFR and IMR) * Eligible for coronary CT-angiography and functional assessment (CT-FFR) Exclusion Criteria: * Patients whose CT-angiography was determined to be non-diagnostic/unreadable during its evaluation * Previous coronary artery bypass grafting with patent grafts to the interrogated vessel * Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis * Critical coronary artery disease deemed by the Heart Team to require immediate revascularization * Contraindication to adenosine (e.g. bronchial asthma) * Chronic renal impairment with severe reduction of glomerular filtration rate (eGFR \<30 ml/min) * Presence of cardiogenic shock * Participation in another interventional study involving the left heart or coronary arteries
Where this trial is running
Leipzig
- Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology — Leipzig, Germany (Recruiting)
Study contacts
- Principal investigator: Robin Gohmann, Dr. — Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
- Study coordinator: Nicolas Majunke, Dr.
- Email: nicolas.majunke@medizin.uni-leipzig.de
- Phone: +49 341 865 1428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.