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Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.

Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05162716
Acronym
CROSS-LEFT-AF
Enrollment
50
Registered
2021-12-17
Start date
2020-05-01
Completion date
2022-10-30
Last updated
2021-12-17

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

Conditions

Pacing-Induced Cardiomyopathy

Keywords

left bundle branch area pacing; atrial fibrillation; atrioventricular ablation; pacing-induced cardiomyopathy

Brief summary

Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing. Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled. They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation. They will be prospectively followed during 6 months.

Detailed description

Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled. They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing confirmed according to electrocardiographic parameters. Atrioventricular node ablation will be performed the following day through a femoral venous approach. Perioperative data and potential complications will be collected. Patients will be prospectively followed during 6 months. They will have clinical examination, 12-lead ECG, and an echocardiography.

Interventions

DEVICESingle-chamber pacemaker implantation with left bundle branch area pacing

A prepectoral single-chamber pacemaker is implanted with a 3830 (Medtronic) IS-1 pacing lead screwed via the right ventricle in the deep interventricular septum in order to capture the left Purkinje system on the left ventricular endocardial side.

Sponsors

Dr Arnaud BISSON
CollaboratorUNKNOWN
Nicolas Clementy, MD, PhD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Permanent atrial arrhythmia * Symptoms related to an insufficient rate control under optimal medical therapy

Exclusion criteria

* Indication of prophylactic defibrillator * Already implanted with a cardiac device

Design outcomes

Primary

MeasureTime frameDescription
Heart failure hospitalization6 monthsHospitalization for decompensated heart failure

Secondary

MeasureTime frameDescription
Mortality6 monthsDeath from any cause
Electrical remodeling6 monthsQRS width
Complications30 daysPerioperative complications
Volumetric response6 monthsLeft ventricular ejection fraction, left ventricular volumes

Countries

France

Contacts

Primary ContactNicolas CLEMENTY
nclementy@yahoo.fr+33618072141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026