Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle. (CROSS LEFT)

October 20, 2021 updated by: Nicolas Clementy, MD, PhD, University Hospital, Tours

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Please Select...
      • Tours, Please Select..., France, 37000
        • Chru De Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
A dual-chamber DF-1 defibrillator is implanted. Left bundle branch area pacing is performed for cardiac resynchronization therapy.
Other Names:
  • Cardioverter-defibrillator implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with successful defibrillation at 35 Joules.
Time Frame: 24 hours
After manual induction of ventricular fibrillation, a 35 Joules will be delivered with the implanted defibrillator.
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Actual)

July 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROSS LEFT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD may be shared with manuscript reviewers, upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Left Bundle Branch Area Pacing

Clinical Trials on Left bundle branch area pacing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe