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

NCT04970082 | Completed

• 1 other identifier: 2021-A00947-34
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Stenosis; Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperative

Secondary Outcomes (3)

• Number of participants with Adverse Events

  Intraoperative

• Tolerance

  Intraoperative

• correlation between a disproportionately high FFR value and la presence of a (partially) infarcted territory

  Intraoperative

Study Arms (2)

FFR followed by FFR-DWP (investigation)

EXPERIMENTAL

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

Diagnostic Test: FFR DWP; Diagnostic Test: FFR

FFR-DWP (investigation) followed by FFR

EXPERIMENTAL

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

Diagnostic Test: FFR DWP; Diagnostic Test: FFR

Interventions

FFR DWP DIAGNOSTIC_TEST

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

FFR followed by FFR-DWP (investigation); FFR-DWP (investigation) followed by FFR

FFR DIAGNOSTIC_TEST

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

FFR followed by FFR-DWP (investigation); FFR-DWP (investigation) followed by FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Recherche Cardio Vasculaire Alpes: lead

Study Sites (1)

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Benjamin Faurie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 21, 2021
• Study Start: June 17, 2021
• Primary Completion: February 4, 2022
• Study Completion: August 31, 2022
• Last Updated: December 15, 2023

Record last verified: 2022-05

Locations

FR (1)