CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiac Resynchronization Therapy
- Sponsor
- XSpline S.p.A.
- Enrollment
- 150
- Locations
- 13
- Primary Endpoint
- Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Reduction of left ventricular end-systolic volume of at least 15% in 75% of CRT treated patients
Time Frame: 6 months follow-up
Increase in efficacy of CRT using XSpline technology assessed by reduction of left ventricular end-systolic volume of at least 15% at 6-month follow-up in 75% of CRT treated patients, based on routine echo-cardiographic measurements
Secondary Outcomes
- Total X-ray exposure time difference(6 months follow-up)
- CRT procedural time difference(6 months follow-up)
- Feasibility of systematic use of XSpline platform for CRT implantation(6 months follow-up)