Condition: Cardiac Resynchronization Therapy · Chronic Heart Failure · Left Bundle-Branch Block · Sponsor: XSpline S.p.A.
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.
This description comes directly from the study's public registry record.
Claudia M Amatruda, PhD · +390471200372 · amatruda@xspline.com
Always discuss trial participation with your own doctor first.
| Rush University Medical center | Chicago, Illinois, United States | Not Yet Recruiting |
| The University of Chicago Medicine | Chicago, Illinois, United States | Not Yet Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| Duke University Hospital | Durham, North Carolina, United States | Recruiting |
| Ordensklinikum Linz Elisabethinen Hospital | Linz, Austria | Recruiting |
| Semmelweis University | Budapest, Hungary | Not Yet Recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia, Pavia, Italy | Not Yet Recruiting |
| University Tor Vergata | Roma, Roma, Italy | Not Yet Recruiting |
| General Hospital of Bolzano | Bolzano, Italy | Not Yet Recruiting |
| Ospedale S. Maria del Carmine di Rovereto | Rovereto, Italy | Not Yet Recruiting |
| Maastricht University Medical Center | Maastricht, Netherlands | Not Yet Recruiting |
| Univeristat de Barcelona | Barcelona, Spain | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05327062