Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorHeart and Diabetes Center North-Rhine Westfalia

About this trial

Aortic valve stenosis (AS) affects 2-7% of persons \> 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with AS between 40 - 65% . Angina in AS caused by significant reduction of coronary flow reserve (CFR). CFR is the ratio of maximal flow increase in the coronary vessel bed during maximal hyperaemia (medically or exercise induced). FFR (fractional flow reserve) use in patients with AS potentially invalid due to dysfunctional CFR leading to potential undertreatment of CAD in these patients.CFR disturbance in AS mainly due to myocardial overload causing concentric hypertrophy, increased oxygen consumption and neurohormonal activation leading to increased vascular resistance. Current studies are investigating the validity of FFR and iFR in AS patients. Recent data demonstrate very good correlation between FFR and iFR derived values to PET myocardial perfusion imaging values in patients with no evidence of AS. Our study aims to investigate the diagnostic performance of FFR and iFR in intermediate-grade coronary stenosis in patients with severe aortic valve disease and correlate FFR- and iFR derived values with those extracted from PET-perfusion Imaging.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

intolerance of Adenosin

left ventricular ejection fraction < 55%

Trial population

Patients with severe aortic Stenosis eligible for transcatheter aortic Valve Implantation (TAVI) with concurring coronary artery disease.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure

Evaluation of FFR-negative intermediary coronary stenoses in Patients with severe Aortic Stenosis Prior and 3 months following TAVI

Time frame
3 months

Secondary outcomes

1

Clinical Evaluation Prior to and following TAVI

Angina prevalence in patients with intermediate coronary Stenosis Prior to and 3 months following TAVI

Time frame
3 months

Other outcomes

Sponsors and contacts

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