NCT05102227

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

October 4, 2021

Last Update Submit

October 20, 2021

Conditions

Left Bundle Branch Area Pacing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Time from ventricular fibrillation induction to defibrillation shock.

    24 hours

  • Number of appropriate and inappropriate arrhythmic episodes.

    6 months

Study Arms (1)

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.

Device: 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.

Also known as: Cardioverter-defibrillator implantation
LBBAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients with an indication of a new implantation of a cardiac resynchronization therapy system.

You may qualify if:

  • Ischemic or non-ischemic cardiomyopathy
  • Left ventricular ejection fraction ≤35% despite optimal medical therapy
  • Left bundle branch block with QRS ≥130 milliseconds

You may not qualify if:

  • Previously implanted intra-cardiac material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Tours

Tours, Please Select..., 37000, France

Location

Related Publications (1)

  • 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.

    PMID: 35970951DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 4, 2021

First Posted

November 1, 2021

Study Start

March 25, 2021

Primary Completion

July 31, 2021

Study Completion

December 31, 2022

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

FR(1)