Left Bundle Branch Area PacingCROSS LEFTNCT05102227
Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.
An observational study of Left Bundle Branch Area Pacing, run by University Hospital, Tours at 1 site in France.
Trial summary
Evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Bundle Branch Area Pacing
- What is being tested?
- Left bundle branch area pacing
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 25 Mar 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with an indication of a new implantation of a cardiac resynchronization therapy system.
Who may be able to join
- Ischemic or non-ischemic cardiomyopathy
- Left ventricular ejection fraction ≤35% despite optimal medical therapy
- Left bundle branch block with QRS ≥130 milliseconds
Who cannot join
- Previously implanted intra-cardiac material
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Left Bundle Branch Area Pacing
- Being tested
- Left bundle branch area pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left bundle branch area pacingDevice
Also called Cardioverter-defibrillator implantation
A dual-chamber DF-1 defibrillator is implanted. Left bundle branch area pacing is performed for cardiac resynchronization therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Left bundle branch area pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
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.
Measured: 24 hours
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start25 Mar 2021
- Primary completion31 Jul 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Bundle Branch Area PacingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Clementy, MD, PhD, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102227
- Sponsor's protocol ID
- CROSS LEFT
- Acronym
- CROSS LEFT
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared with manuscript reviewers, upon reasonable request.
Publications
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.
PubMed 35970951
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle. The CROSS LEFT Study.
- ClinicalTrials.gov ID
- NCT05102227
- Acronym / sponsor ID
- CROSS LEFT / CROSS LEFT
- Conditions
- Left Bundle Branch Area Pacing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LBBAP | – | Device: Left bundle branch area pacingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with an indication of a new implantation of a cardiac resynchronization therapy system.
Key inclusion criteria (3 listed)
- Ischemic or non-ischemic cardiomyopathy
- Left ventricular ejection fraction ≤35% despite optimal medical therapy
- Left bundle branch block with QRS ≥130 milliseconds
Key exclusion criteria (1 listed)
- Previously implanted intra-cardiac material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left bundle branch area pacingAlso: Cardioverter-defibrillator implantationA dual-chamber DF-1 defibrillator is implanted. Left bundle branch area pacing is performed for cardiac resynchronization therapy. | Device | LBBAP |
Primary outcome
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.
2 secondary outcomes
Time from ventricular fibrillation induction to defibrillation shock.
Time frame: 24 hours
Number of appropriate and inappropriate arrhythmic episodes.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 35970951Clementy 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.
- Individual participant dataSharing planned: Undecided. IPD may be shared with manuscript reviewers, upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Bundle Branch Area Pacing, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with successful defibrillation at 35 Joules. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05102227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021; AzTrials last refreshed its copy on 31 Oct 2026.