About this trial
AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes.
The primary hypothesis is that pacing-induced cardiomyopathy, defined as a decrease in LVEF by 10% or more from baseline to an absolute value below 50%, occurs significantly more frequently in patients receiving RV pacing compared with LBBA pacing. Secondarily, LBBA pacing is expected to maintain comparable procedural safety while providing better cardiac function, resulting in improved quality of life and functional capacity compared with conventional RV pacing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy
Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method)
AV node ablation scheduled independently of possible study participation
Age ≥ 18 years
Disqualifiers
Impaired LVEF (< 50%)
Pre-implanted pacemaker
Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details)
High grade (III°) left cardiac valvular disease
Trial design
Parallel
Treatments tested in this trial
RV pacing
Procedure/SurgeryRV apical pacemaker implantation prior to AV node ablation
LBBA pacing
Procedure/SurgeryLBBA pacemaker implantation prior to AV node ablation
Treatment groups
Trial outcomes
Primary outcomes
Number of patients developing pacemaker-induced cardiomyopathy
Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of \< 50%
Secondary outcomes
Left ventricular function
Left ventricular ejection fraction (%)
Left Ventricular Global Longitudinal Strain
Global longitudinal strain of the left ventricle (%)
Right ventricular function
Tricuspid Annular Plane Systolic Excursion (mm)
Right ventricular function
Right Ventricle - Pulmonary Artery Coupling (mm/mmHg)
Sponsors and contacts
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