Skip to main content
Clinical Trials/NL-OMON56818
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Sponsor
XSpline S.p.A.

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

Similar Trials