An observational study in Pacing-Induced Cardiomyopathy, sponsored by Nicolas Clementy, MD, PhD. Status unknown at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-12-17.
Sponsored by Nicolas Clementy, MD, PhD · Observational
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.
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 50 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.
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Patients indicated with pacemaker implantation and atrioventricular junction ablation for symptomatic chronic atrial arrhythmia.
Exclusion Criteria:
Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.
Device: Single-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.
Also known as: Atrioventricular junction ablation
Heart failure hospitalization
Hospitalization for decompensated heart failure
Time frame: 6 months
Mortality
Death from any cause
Time frame: 6 months
Electrical remodeling
QRS width
Time frame: 6 months
Complications
Perioperative complications
Time frame: 30 days
Volumetric response
Left ventricular ejection fraction, left ventricular volumes
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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