NCT05102227UnknownNot Applicable
Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle. The CROSS LEFT Study.
University Hospital, Tours1 site in 1 country10 target enrollmentStarted: March 25, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University Hospital, Tours
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of patients with successful defibrillation at 35 Joules.
Study Overview
Brief Summary
Evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ischemic or non-ischemic cardiomyopathy
- •Left ventricular ejection fraction ≤35% despite optimal medical therapy
- •Left bundle branch block with QRS ≥130 milliseconds
Exclusion Criteria
- •Previously implanted intra-cardiac material
Outcomes
Primary Outcomes
Number of patients with successful defibrillation at 35 Joules.
Time Frame: 24 hours
After manual induction of ventricular fibrillation, a 35 Joules will be delivered with the implanted defibrillator.
Secondary Outcomes
- Time from ventricular fibrillation induction to defibrillation shock.(24 hours)
- Number of appropriate and inappropriate arrhythmic episodes.(6 months)
Investigators
Nicolas Clementy, MD, PhD
Associate Professor
University Hospital, Tours
Study Sites (1)
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