Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.

NCT ID: NCT05102227

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-25

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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Conditions

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Left Bundle Branch Area Pacing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LBBAP

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.

Left bundle branch area pacing

Intervention Type DEVICE

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

Interventions

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Left bundle branch area pacing

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

Intervention Type DEVICE

Other Intervention Names

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Cardioverter-defibrillator implantation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Clementy, MD, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHRU de Tours

Tours, Please Select..., France

Site Status

Countries

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France

References

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Clementy N, Bodin A, Ah-Fat V, Babuty D, Bisson A. Dual-chamber ICD for left bundle branch area pacing: the cardiac resynchronization and arrhythmia sensing via the left bundle (cross-left) pilot study. J Interv Card Electrophysiol. 2023 Jun;66(4):905-912. doi: 10.1007/s10840-022-01342-6. Epub 2022 Aug 16.

Reference Type DERIVED
PMID: 35970951 (View on PubMed)

Other Identifiers

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CROSS LEFT

Identifier Type: -

Identifier Source: org_study_id