Examining heart blood flow in patients with severe aortic valve narrowing
Official title: Correlation of FFR and iFR With Cardiac PET Perfusion (at Rest and Under Adenosine) in the Evaluation of Intermediate Coronary Stenoses in Patients With Severe Aortic Valve Stenosis
Run by Heart and Diabetes Center North-Rhine Westfalia · NCT04882488 · Data updated 2026-11-12
This study tests how two heart flow measurements can help doctors understand and treat patients with severe aortic valve narrowing and coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Heart and Diabetes Center North-Rhine Westfalia Academic / other |
| Locations | 1 site (Bad Oeynhausen, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | June 30, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | November 26, 2024 |
| Trial ID | NCT04882488 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients over 65 years old with severe aortic stenosis and a left ventricular ejection fraction greater than 55%.
✕Probably not a fit
Patients who have a left ventricular ejection fraction below 55% or intolerance to adenosine may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the relationship between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) with cardiac PET perfusion imaging in patients suffering from severe aortic valve stenosis. The study aims to understand how these measurements correlate with coronary artery disease, which is common in patients with aortic stenosis. By evaluating patients who are eligible for transcatheter aortic valve replacement, the study seeks to determine the effectiveness of FFR and iFR in assessing coronary flow reserve and guiding treatment decisions. The findings could help improve the management of patients with concurrent aortic stenosis and coronary artery disease.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing and treating coronary artery disease in patients with severe aortic valve stenosis.
How similar studies have gone: Other studies have shown promising correlations between FFR, iFR, and myocardial perfusion imaging in similar patient populations, suggesting that this approach is supported by existing research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with severe aortic Stenosis eligible for transcatheter aortic stenosis * left ventricular ejection fraction \> 55% * no intolerance of Adenosin * no history of bradycardia, atrioventricular Blockade * intermediate coronary Stenosis with FFR\> 0.8 * Age \>65 Exclusion Criteria: * intolerance of Adenosin * left ventricular ejection fraction \< 55%
Where it's running
-
Herz- und Diabeteszentrum, NRW
Bad Oeynhausen, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Principal investigator: Tanja Rudolph, MD — Consultant physician
- Study coordinator: Tanja Rudolph, MD
- Email: trudolph@hdz-nrw.de
- Phone: +495731971258
Similar studies
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μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease
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Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.