AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Josefs-Hospital Wiesbaden GmbH

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • RV pacing

    Procedure/Surgery

    RV apical pacemaker implantation prior to AV node ablation

  • LBBA pacing

    Procedure/Surgery

    LBBA pacemaker implantation prior to AV node ablation

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Right ventricular pacingActive comparator 1 intervention
Group B: Left bundle branch area pacingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients developing pacemaker-induced cardiomyopathy

Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of \< 50%

Time frame
36 months

Secondary outcomes

1

Left ventricular function

Left ventricular ejection fraction (%)

Time frame
36 months
2

Left Ventricular Global Longitudinal Strain

Global longitudinal strain of the left ventricle (%)

Time frame
36 months
3

Right ventricular function

Tricuspid Annular Plane Systolic Excursion (mm)

Time frame
36 months
4

Right ventricular function

Right Ventricle - Pulmonary Artery Coupling (mm/mmHg)

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.