Clinical trials

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Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: XSpline S.p.A.Updated: Oct 24, 2024Locations: 13
Eligibility criteria

Appropriately signed and dated informed consent. [+9]

History of persistent or permanent atrial fibrillation [+17]