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
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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,
๐ 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.
๐ฐ 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.
Explore by condition: All Cardiac Resynchronization Therapy clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.