Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment (NCT05327062)
🩺 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 — Chicago, Illinois
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Rush University Medical center — Chicago, Illinois
- The University of Chicago Medicine — Chicago, Illinois
- Massachusetts General Hospital — Boston, Massachusetts
- Duke University Hospital — Durham, North Carolina
- Ordensklinikum Linz Elisabethinen Hospital — Linz,
- Semmelweis University — Budapest,
- Fondazione IRCCS Policlinico San Matteo — Pavia, Pavia
- University Tor Vergata — Roma, Roma
- General Hospital of Bolzano — Bolzano,
- Ospedale S. Maria del Carmine di Rovereto — Rovereto,
- Maastricht University Medical Center — Maastricht,
- Univeristat de Barcelona — Barcelona,
- Istituto Cardiocentro Ticino — Lugano,
💰 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 § 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.