A Study to Evaluate Direct Wire Pacing (DWP) for Measuring Fractional Flow Reserve (FFR)

NCT ID: NCT04970082

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2022-08-31

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.

Conditions

Coronary Artery Stenosis; Fractional Flow Reserve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

FFR followed by FFR-DWP (investigation)

The FFR measurement is performed with the standard method first followed by the FFR measurement with the DWP method.

Group Type: EXPERIMENTAL

FFR DWP

Intervention Type: DIAGNOSTIC_TEST

FFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method.

FFR

Intervention Type: DIAGNOSTIC_TEST

FFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method.

FFR-DWP (investigation) followed by FFR

The FFR measurement is performed with the DWP method first followed by the FFR measurement with the standard method.

Group Type: EXPERIMENTAL

FFR DWP

Intervention Type: DIAGNOSTIC_TEST

FFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method.

FFR

Intervention Type: DIAGNOSTIC_TEST

FFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method.

Interventions

FFR DWP

FFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method.

Intervention Type: DIAGNOSTIC_TEST

FFR

FFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Recherche Cardio Vasculaire Alpes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Faurie

Role: PRINCIPAL_INVESTIGATOR

Locations

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, , France

Countries

France

Other Identifiers

2021-A00947-34

Identifier Type: -

Identifier Source: org_study_id