Research: Answering Critical Questions About Transcatheter Valve Replacement and Repair Procedures

The STS/ACC TVT RegistryTM is well positioned to help researchers examine critical questions on the delivery and outcomes of TAVR procedures. The registry’s datasets hold answers to complex questions related to patient risk factors and outcomes, procedure and treatment trends, guidelines adherence, and device, facility and provider characteristics.

Submitting a Research Proposal

The STS/ACC TVT Registry’s investigator-lead research and publications process allows investigators to submit research proposals based on analysis of limited datasets from the registry.

Research proposals are intended for hypothesis-driven studies based upon secondary analysis of registry data, with the intent to develop manuscripts suitable for peer-reviewed publication. Actual datasets are not released. Specific information about the data collected by the STS/ACC TVT Registry can be found on the Data Collection page.

Proposed studies require the completion of a formal research proposal application (RPA) through the online research management system rp.acc.org. When an investigator submits an RPA, the proposed project enters the STS/ACCTVT Registry (R&P) pipeline. Submitted proposals are reviewed for scientific merit and undergo a competitive approval process for funding, which is used to support analysis conducted by a contracted data analytic center

The TVT Registry R&P pipeline process includes:

  1. Proposal evaluation, prioritization, and approval by the STS/ACC TVT Registry Research and Publication Subcommittee
  2. Analysis by an STS/ACC TVT Registry-designated analytic center
  3. Oversight of manuscript and abstract preparation, review and submission

Patient, hospital and physician confidentiality is always protected. All projects are supervised by the TVT Registry R&P committee to ensure adherence to data access and use policies and procedures, as well as relevant regulations.

Steps for Submitting an RPA:

To ensure that your proposal has the best chance for acceptance, please follow the guidelines below before drafting your research proposal application:

  1. Review the NCDR Research Policies and Procedures and the TVT Registry RPA submission FAQs.

  2. Check the TVT Registry Research Calendar for submission deadlines.
      
  3. Review the registry data collection forms to confirm that the registry collects the data needed for your proposal.

  4. Ensure your research proposal idea has no overlap with in-progress or published work. Lists of published and unpublished projects are provided above.

  5. Determine which funding source you will select on your RPA form:

    • Researchers with projects not supported by a grant or industry funding should select “NCDR funding” on the RPA form (most common funding source).
    • Funding goes towards the cost of data analytics, which includes the analysis for a manuscript and an abstract.
    • Analytics must be conducted at a TVT Registry-designated data analytic center. The registry does not send datasets to individual investigators or organizations.
    • If you have grant, institution, industry, or another external source of funding, please complete the preliminary proposal for non-NCDR funded research form and email it to tvtresearch@acc.org before preparing a proposal. Investigators are encouraged to contact the registry early in the funding exploration phase.
    • All STS/ACC TVT Registry research studies must adhere to the same oversight processes regardless of funding source for the research activities; therefore, obtaining funding does not automatically guarantee the research study will be approved. Applicants with their own source of funding may apply at any time. Reviews are conducted on a rolling basis. Remember that if you have your own funding, you must have enough to cover costs to our contracted analytic centers, as we do not pass the data on to individuals to do their own statistical analyses. If external funding is not awarded, proposals may be submitted for STS/ACC funding by the deadline of the next scheduled committee meeting. Staff must be notified of the submission.
  6. Determine if the 'Rule of Two' applies to you. The NCDR 'Rule of Two' applies across all NCDR programs and applies to both NCDR funded and non-NCDR funded research. An active proposal is one that has been submitted to NCDR for Committee review but has not yet resulted in the publication of a manuscript to a peer-reviewed journal (i.e. a research proposal anywhere between application submission and publication). If a principal investigator has submitted two proposals for review, both need to go through the entire NCDR research process before submitting another proposal. If both RPAs are approved and move forward to analysis, the investigator cannot submit another RPA until at least one of the ‘active’ proposals have resulted in a manuscript publication.

  7. When you are ready to submit your research proposal, log into rp.acc.org using your existing ACC.org credentials, or create a new account. Creating an account is free.

  8. Review the R&P Resources Page (located in the top navigation bar) at rp.acc.org:
    • Research Portal User Guide
    • National Cardiovascular Data Registry Investigator’s Guide: RESEARCH POLICIES AND PROCEDURES
    • Investigator’s Guide to Submitting a Research Proposal Application
    • Investigator’s Guide to Submitting an Abstract & Manuscript
    • National Cardiovascular Data Registry Investigator Responsibilities Checklist
  9. Once your application is received by the registry, you will receive a confirmation email from ncdrresearch@acc.org along with an assigned tracking number. If it passes preliminary screening, your submission will then move forward for committee review. You can access updates on where your proposal is within the review process by logging into the research portal. Your RPAs should appear in the homepage.

For Questions about TVT Registry Research

Contact us at tvtresearch@acc.org or 800-257-4737 Monday through Friday between 9 a.m. and 5 p.m. ET.

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