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

Primary Purpose

Coronary Artery Stenosis, Fractional Flow Reserve

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FFR DWP
FFR
Sponsored by
Centre Recherche Cardio Vasculaire Alpes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupe Hospitalier Mutualiste de Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FFR followed by FFR-DWP (investigation)

FFR-DWP (investigation) followed by FFR

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reproducibility of the FFR measurement
Evaluated by the number of patients with comparable FFR ratio recording. The FFR ratio should remain constant (+/-0.02) between the two modes of measuring FFR.

Secondary Outcome Measures

Number of participants with Adverse Events
Assessed by the number of participants with adverse events during the procedure.
Tolerance
Assessed by asking patients during each FFR to grade verbally any symptoms of chest discomfort.
correlation between a disproportionately high FFR value and la presence of a (partially) infarcted territory
The correlation between a disproportionately high FFR value in presence of a (partially)infarcted territory will be assessed by the comparison the obtained FFR value, the degree of angiographic stenosis measured and the obtained stimulation threshold.

Full Information

First Posted
July 16, 2021
Last Updated
June 13, 2022
Sponsor
Centre Recherche Cardio Vasculaire Alpes
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1. Study Identification

Unique Protocol Identification Number
NCT04970082
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Recherche Cardio Vasculaire Alpes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis, Fractional Flow Reserve

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFR followed by FFR-DWP (investigation)
Arm Type
Experimental
Arm Description
The FFR measurement is performed with the standard method first followed by the FFR measurement with the DWP method.
Arm Title
FFR-DWP (investigation) followed by FFR
Arm Type
Experimental
Arm Description
The FFR measurement is performed with the DWP method first followed by the FFR measurement with the standard method.
Intervention Type
Diagnostic Test
Intervention Name(s)
FFR DWP
Intervention Description
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
Intervention Name(s)
FFR
Intervention Description
FFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method.
Primary Outcome Measure Information:
Title
Reproducibility of the FFR measurement
Description
Evaluated by the number of patients with comparable FFR ratio recording. The FFR ratio should remain constant (+/-0.02) between the two modes of measuring FFR.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events
Description
Assessed by the number of participants with adverse events during the procedure.
Time Frame
Intraoperative
Title
Tolerance
Description
Assessed by asking patients during each FFR to grade verbally any symptoms of chest discomfort.
Time Frame
Intraoperative
Title
correlation between a disproportionately high FFR value and la presence of a (partially) infarcted territory
Description
The correlation between a disproportionately high FFR value in presence of a (partially)infarcted territory will be assessed by the comparison the obtained FFR value, the degree of angiographic stenosis measured and the obtained stimulation threshold.
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Faurie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Mutualiste de Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

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

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