Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.

N/AUnknownNCT05102227

University Hospital, Tours10 enrolled

Overview

Evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Left Bundle Branch Area Pacing

Interventions

Left bundle branch area pacingDEVICE

A dual-chamber DF-1 defibrillator is implanted. Left bundle branch area pacing is performed for cardiac resynchronization therapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHRU de Tours

Tours, Please Select..., France

Outcomes

Primary Outcomes

Number of patients with successful defibrillation at 35 Joules.

After manual induction of ventricular fibrillation, a 35 Joules will be delivered with the implanted defibrillator.

Time frame: 24 hours

Secondary Outcomes

Time from ventricular fibrillation induction to defibrillation shock.

After manual induction of ventricular fibrillation, the duration of appropriate ventricular sensing will be measured until the 35 Joules shock is delivered.

Time frame: 24 hours

Number of appropriate and inappropriate arrhythmic episodes.

The occurrence of appropriately or inappropriately detected episodes with a high ventricular rate ≥170 beats-per-minute will be recorded.

Time frame: 6 months

Data from ClinicalTrials.gov

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