Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.

• Conditions: Left Bundle Branch Area Pacing
• Interventions: Device: Left bundle branch area pacing

• Registration Number: NCT05102227
• Lead Sponsor: University Hospital, Tours

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-25
• Primary Completion: 2021-07-31
• Status Verified: 2021-10
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-20
• Last Update Submitted: 2021-10-20
• Study First Posted: 2021-11-01
• Last Update Posted: 2021-11-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LBBAP	Left bundle branch area pacing	Patients implanted with a dual-chamber DF-1 cardioverter-defibrillator. Ventricular tachy sensing is performed via an IS-1 pacing lead placed in the interventricular septum.

Primary Outcome Measures

Name	Time	Method
Number of patients with successful defibrillation at 35 Joules.	24 hours	After manual induction of ventricular fibrillation, a 35 Joules will be delivered with the implanted defibrillator.

Secondary Outcome Measures

Name	Time	Method
Time from ventricular fibrillation induction to defibrillation shock.	24 hours	After manual induction of ventricular fibrillation, the duration of appropriate ventricular sensing will be measured until the 35 Joules shock is delivered.
Number of appropriate and inappropriate arrhythmic episodes.	6 months	The occurrence of appropriately or inappropriately detected episodes with a high ventricular rate ≥170 beats-per-minute will be recorded.

Trial Locations

Locations (1)

CHRU de Tours; 🇫🇷 Tours, Please Select..., France