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RecruitingNCT04882488TAVI PETUpdated Nov 26, 2024

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

An observational study in Aortic Valve Stenosis and Coronary Artery Disease, sponsored by Heart and Diabetes Center North-Rhine Westfalia. Recruiting at 1 site in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Heart and Diabetes Center North-Rhine Westfalia · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
65 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Aortic Valve Stenosis
  • Coronary Artery Disease

Keywords

  • Aortic valve stenosis
  • PET-CT
  • coronary artery disease
  • FFR
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's planned enrollment of 20 is below the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia is the lead sponsor of 33 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • intolerance of Adenosin
  • left ventricular ejection fraction \< 55%
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
None retained
06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Herz- und Diabeteszentrum, NRW
    Bad Oeynhausen, NRW 32545, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04882488
Lead sponsor
Heart and Diabetes Center North-Rhine Westfalia
Responsible party
Sponsor
First posted
May 12, 2021
Start date
Jun 1, 2021
Primary completion
Jun 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Nov 26, 2024

Study contacts

Tanja Rudolph, MD
Contact
trudolph@hdz-nrw.de
+495731971258
Astrid Kleemeyer
Contact
akleemeyer@hdz-nrw.de
+49495731971258
Tanja Rudolph, MD
principal investigator · Consultant physician

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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