The HeartFlow ADVANCE Registry
Research type
Research Study
Full title
The HeartFlow ADVANCE Registry: Assessing Diagnostic Value of Non-invasive FFRct in Coronary CarE
IRAS ID
208445
Contact name
Timothy Fairbairn
Contact email
Sponsor organisation
HeartFlow, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
FFRct is a noninvasive method to evaluate the hemodynamic significance of coronary artery lesions and is calculated from subject-specific coronary computed tomography angiogram (cCTA).
The HeartFlow ADVANCE Registry is an on-label, post-market, multi-center, prospective registry designed to evaluate utility, clinical outcomes and resource utilization following FFRct-guided treatment. FFRct is CE marked and shall be used in accordance with the current labeling indications and instructions.
The OVERALL OBJECTIVE of the HeartFlow ADVANCE Registry is to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis and management of coronary artery disease (CAD).
Specific Objectives of the Registry are:
- To determine if the availability of FFRct, in addition to coronary anatomy from the cCTA, will lead to a significant change in the coronary management plan.
-To assess the real world outcomes of utilizing cCTA to guide invasive management and/or medical treatment.
-To assess resource utilization, following standard practice for diagnostic and treatment pathways incorporating FFRct as the preferred CAD diagnostic test.
-To provide society including patients, health care providers, and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD.
Up to 5000 clinically stable, symptomatic patients diagnosed by cCTA to have CAD will be enrolled at up to 50 hospitals in Europe, United States, Canada and Asia. Subjects will need to have cCTA showing CAD to be able to participate in the Registry. Follow up contact of patients by phone will occur at 90 days, 180 days, 1 year, 2 years and 3 years.
The Primary Endpoint is the reclassification rate between the coronary management plan based on the review of the cCTA compared to the management plan based on FFRct, when obtained, as assessed by an independent review committee. Secondary Endpoints include analysis of the Major Adverse Coronary Event rates, estimated cumulative medical radiation exposure and resource utilization.
REC name
North of Scotland Research Ethics Committee 2
REC reference
16/NS/0070
Date of REC Opinion
13 Jul 2016
REC opinion
Further Information Favourable Opinion