Clinical trial NCT04970082: A Study to Evaluate Direct Wire Pacing (DWP) for Measuring Fractional Flow Reserve (FFR)
Official title: A Randomized Crossover Study to Evaluate and Compare the Reproducibility and Tolerability of Direct Wire Pacing for Measuring Fractional Flow Reserve Versus Standard Method in Subjects With FFR Indications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Stenosis
Fractional Flow Reserve
Lead sponsor: Centre Recherche Cardio Vasculaire Alpes
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This is a randomized, non-inferiority, crossover investigation comparing the Direct Wire Pacing (DWP) versus standard method to measure Fractional Flow Reserve (FFR) in subjects with FFR indications.

All subjects requiring on a clinical basis a pressure wire assessment of coronary artery stenosis(es) will be eligible to take part in the study.

Detailed description: Pressure wire-based Fractional Flow Reserve (FFR) has become the reference standard index of haemodynamic significance to guide revascularisation of intermediate coronary artery lesions.

The FFR measurement determines the ratio of the maximum blood flow that can be achieved in a diseased or narrowed coronary artery to the maximum blood flow in a normal coronary artery. This ratio represents the potential decrease in distal coronary flow relative to coronary stenosis.

FFR is easily measured during routine coronary angiography using a pressure wire to calculate the ratio of coronary pressure distal to a stenosis or diseased segment to aortic pressure under conditions of maximum myocardial hyperemia. An FFR of 1.0 is widely accepted as normal. An FFR of less than 0.80 is generally considered to be associated with coronary ischemia and widely accepted in favor of revascularization rather than conservative management.

The current standard method of measuring FFR is to insert a pressure wire into the coronary artery while the hyperaemic agent, usually adenosine, is delivered by intracoronary bolus or continuous intravenous injection.

Administration of adenosine may cause bradycardia and thus cause patient vagal discomfort. Direct Wire Pacing (DWP) can potentially overcome the drawbacks of the standard method when measuring FFR. Indeed, DWP allows to transmit an electrical current from the external pacemaker to the heart thanks to metallic FFR guidewire already used, and thus prevent bradycardia.

In addition, there are some absolute contraindications to the use of Adenosine such as 2nd or 3rd degree atrioventricular block, untreated sinus dysfunction or long QT syndrome ...DWP could allow this highly recommended diagnostic tool (1A) to be used in this patient population.

The investigators would therefore like to determine if the measurement of FFR by DWP would be non-inferior to the standard method to obtain precise FFR values and maximize patient's comfort.

Eligibility criteria: Eligible patient for coronary angiography.

Inclusion Criteria:

The patients included in the study must meet the following inclusion criteria :

* Patients ≥ 18 years old
* Patients with FFR indications
* Has given consent to undergo diagnostic coronary procedure
* Patients able to understand and provide informed consent
* Patients with Social Security coverage

Prior to randomisation: Angiography demonstrates at least one coronary stenosis in an artery, requiring FFR measurement for physiological assessment.

Exclusion Criteria:

The patients included in the study should not meet the following inclusion criteria :

* Contraindications to use sensitivity to Adenosine or any of its excipients
* Technically inaccessible stenosis(es)
* Pregnant or breastfeeding woman
* Patients under judicial protection, tutorship or curatorship
* Patient participating in another interventional clinical trial

Primary outcomes:
measure: Reproducibility of the FFR measurement
timeFrame: Intraoperative
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: Intraoperative
measure: Tolerance
timeFrame: Intraoperative
measure: correlation between a disproportionately high FFR value and la presence of a (partially) infarcted territory
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
Study officials:
name: Benjamin Faurie
role: PRINCIPAL_INVESTIGATOR
References: