Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Recruiting now · Not applicable
Conditions studied: Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
In brief
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.
Key facts
- Study ID
- NCT05327062
- Run by
- XSpline S.p.A.
- People needed
- 150
- Starts
- 2023-03-06
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2024-10-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Duke University Hospital — Durham, North Carolina, United States (enrolling)
- Ordensklinikum Linz Elisabethinen Hospital — Linz, Austria (enrolling)
- Univeristat de Barcelona — Barcelona, Spain (enrolling)
- Istituto Cardiocentro Ticino — Lugano, Switzerland (enrolling)
- General Hospital of Bolzano — Bolzano, Italy
- Ospedale S. Maria del Carmine di Rovereto — Rovereto, Italy
- Maastricht University Medical Center — Maastricht, Netherlands
- Fondazione IRCCS Policlinico San Matteo — Pavia, Pavia, Italy
- The University of Chicago Medicine — Chicago, Illinois, United States
- Semmelweis University — Budapest, Hungary
- Rush University Medical center — Chicago, Illinois, United States
- University Tor Vergata — Roma, Roma, Italy
Full record on ClinicalTrials.gov
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