NL-OMON56818
Not yet recruiting
Not Applicable
CRT-DRIVE: Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment - CRT-DRIVE
XSpline S.p.A.0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Symptomatic heart failure
- Sponsor
- XSpline S.p.A.
- Enrollment
- 10
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed Consent signed by the subject
- •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
- •Patients in Sinus Rhythm, who are scheduled for CRT device implantation in
- •less than 3
- •QRS duration \>\=130 ms
- •Left bundle branch block
- •Left ventricular ejection fraction \<\=35%
Exclusion Criteria
- •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 • Patients with
- •unstable angina • Subject experienced a recent myocardial infarction, within 40
- •days prior to enrollment • Subject underwent coronary artery bypass graft or
- •valve surgery, within 90 days prior to enrollment • Subject is post heart
- •transplantation, or is actively listed on the transplantation list, or has
- •reasonable probability (per investigator\*s discretion) of undergoing
- •transplantation in the next year • Subject is implanted with a left ventricular
- •assist device • Subject is on continuous or uninterrupted infusion (inotropic)
Outcomes
Primary Outcomes
Not specified
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