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Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05102227
Acronym
CROSS LEFT
Enrollment
10
Registered
2021-11-01
Start date
2021-03-25
Completion date
2022-12-31
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Bundle Branch Area Pacing

Brief summary

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

Interventions

DEVICELeft bundle branch area pacing

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

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with successful defibrillation at 35 Joules.24 hoursAfter manual induction of ventricular fibrillation, a 35 Joules will be delivered with the implanted defibrillator.

Secondary

MeasureTime frameDescription
Time from ventricular fibrillation induction to defibrillation shock.24 hoursAfter 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 monthsThe occurrence of appropriately or inappropriately detected episodes with a high ventricular rate ≥170 beats-per-minute will be recorded.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026