• Recent News:   NICE Guidance Recommends HeartFlow Analysis
  • X

External and Investigator Initiated
Research Program

Program Overview

The HeartFlow External Research Program was designed so that investigators, organizations, and industry have an avenue for utilizing HeartFlow technology as part of their study programs in the pursuit of original cardiovascular research and to advance the use of FFRCT to improve human heart health. The ultimate goal of this program is to advance clinical and scientific knowledge of HeartFlow technology and the treatment of cardiovascular disease. This program is open to all academic and community-based physicians and researchers who are interested in conducting their own research.

Typical categories of research that can be submitted for consideration to this program include:

  • Investigator-initiated studies (IIS)
  • Industry-sponsored studies using FFRCT as a study endpoint (e.g. pharmaceutical or medical device research)
  • Studies sponsored by non-profit groups or other research consortiums

Eligible external research projects are designed, implemented, and sponsored by independent clinical investigators, organizations, or industry sponsors. HeartFlow does not design, conduct, or supervise the research aspects of the proposed study, but may provide limited scientific, technical, data analysis or training assistance related to HeartFlow’s technology.

Any investigator, organization, or industry group requesting research support from HeartFlow will serve as the sponsor of the proposed study and will be expected to perform the responsibilities of ‘sponsor’ as defined by the United States Code of Federal Regulations (21 CFR, Subpart D) and ICH Guidelines for Good Clinical Practices (GCP) concerning Sponsor Responsibilities, as applicable. Sponsor responsibilities include, but are not limited to:

  • Designing the protocol and conducting the scientific investigation;
  • Understanding and complying with any local regulatory requirements;
  • Monitoring the study;
  • Reporting safety data to regulatory authorities, the IRB (Institutional Review Board)/EC (Ethics Committee), and HeartFlow, as applicable; and
  • Registering the study on a public web site or any other venue required by law (e.g. www.clinicaltrials.gov).

HeartFlow will not formally commit to provide support for any proposed project without a thorough scientific review of study-related materials and without verification that the research has been approved by proper governing bodies (e.g. IRB, EC, and FDA, as applicable). Upon review of the study materials, HeartFlow may provide comments or revisions to the requester regarding the proposed materials.

Proposals are evaluated based upon a variety of factors, including: scientific merit, feasibility to complete the study and publish results, originality of the proposal, and alignment with company focus. During the review, HeartFlow will also evaluate whether an applicant is qualified to receive support based upon the factors that include, but are not limited to: appropriate credentials, education, reputation, demonstrable relevant expertise, research background and training, knowledge of disease or therapeutic area in which the research will be conducted, lack of regulatory authority (e.g., FDA) debarment/disqualification or exclusion and disciplinary action or pending action by any professional licensing body, and ability and potential to successfully conduct the research for which support is requested (including staffing and site resources).

HeartFlow has limited resources and many studies, however the company may support eligible studies by providing HeartFlow products at agreed-upon rates, and by offering limited other research grants, depending on the scope of the project.

Submission and Review Process

Electronic submissions should be made through the link provided at the end of this page.
The average total length of time from submission to communication of the decision regarding support ranges from one to six months, depending on a number of factors. Additional review time may be required as needed.

  1. A complete online submission must be received in order for a research request to be considered by HeartFlow for review. This submission must include a complete protocol, basic information about the study and sponsor, curriculum vitae of the investigator, study objectives, expected timelines, the type of support that is being requested (for financial requests a detailed budget proposal will need to be attached), publication plan, and any other relevant details.
  2. HeartFlow will acknowledge receipt of all research submission requests via e-mail.
  3. A HeartFlow committee with clinical, medical, regulatory, and technical expertise will review each submission. Decisions for support are made based on scientific merit as well as available resources and current company/research priorities, and within allowable indications per the current Instructions For Use. Investigators should allow at least 3-4 weeks for the initial committee review after a complete submission is received by HeartFlow.
  4. A formal notification concerning the status of each application (approved, declined, or more information required) will be provided once the research proposal has been reviewed.

Approved Submissions

Upon approval of a research request, HeartFlow requires that the following are in place before initiating formal study support:

  • A signed Clinical Study Agreement, or equivalent agreement, based on the scope of the project;
  • Verification of IRB/Ethics Committee Approval or equivalent, as applicable;
  • Installation of HeartFlow Connect at the relevant Institution(s); and
  • A final study protocol or synopsis.

Once a proposal is approved, no changes will be allowed to any part of the approved project (i.e. protocol, budget, etc.) absent HeartFlow’s prior written agreement.

Study Management

HeartFlow requires the sponsor to provide periodic study status updates (including protocol amendments, enrollment progress, study timeline changes, planned publications).

Data Privacy

HeartFlow will process any submitted personal and research information only for the purposes of evaluating the submission and administering any resultant ongoing relationship with the potential study sponsor, and otherwise in accordance with the HeartFlow’s Privacy Policy. For more information, view HeartFlow’s Privacy Policy.


Online Submission Form

Questions?

If you have additional questions on the External and Investigator Initiated
research programs, please contact us at

clinicalresearch@heartflow.com