Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.

Left Bundle Branch Area Pacing Clinical Trial

— CROSS LEFT  

Official title:

Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle. The CROSS LEFT Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05102227
• Other study ID #: CROSS LEFT
• Status: Active, not recruiting
• Start date: March 25, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Left Bundle Branch Area Pacing

Intervention

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

Locations

Country	Name	City	State
France	CHRU de Tours	Tours	Please Select...

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	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.	24 hours
Secondary	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.	6 months