Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXSpline S.p.A.
About this trial
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.
Eligibility criteria
Qualifiers
Appropriately signed and dated informed consent.
Age ≥18 years at time of consent.
CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA guidelines (COR I).
Sinus rhythm
Disqualifiers
History of persistent or permanent atrial fibrillation
Previous pacemaker or ICD implantation
Indication to pacing due to bradycardia
Patients considered for His bundle pacing or cardiac conduction pacing
Trial design
Treatments tested in this trial
- CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov