๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-10-22

Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment (NCT05327062)

CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: XSpline S.p.A.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region. Study Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.

Who can join: Review the eligibility criteria below.

Location: Rush University Medical center โ€” Chicago, Illinois

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (13 Sites)

  • Rush University Medical center โ€” Chicago, Illinois
  • The University of Chicago Medicine โ€” Chicago, Illinois
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Duke University Hospital โ€” Durham, North Carolina
  • Ordensklinikum Linz Elisabethinen Hospital โ€” Linz,
  • Semmelweis University โ€” Budapest,
  • Fondazione IRCCS Policlinico San Matteo โ€” Pavia, Pavia
  • University Tor Vergata โ€” Roma, Roma
  • General Hospital of Bolzano โ€” Bolzano,
  • Ospedale S. Maria del Carmine di Rovereto โ€” Rovereto,
  • Maastricht University Medical Center โ€” Maastricht,
  • Univeristat de Barcelona โ€” Barcelona,
  • Istituto Cardiocentro Ticino โ€” Lugano,

๐Ÿ“ž Contact the Study Coordinator

Phone: +390471200372

Email: amatruda@xspline.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—