Health TrialsbyHealthPanel

Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction

ConditionsHeart FailureBlock, HeartPacing-Induced Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsorsrdpiers

About this trial

It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years with permanent AF and LVEF < 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy.

Expected percentage of ventricular pacing > 40%

≥ 3 months of heart failure medication optimization

Disqualifiers

Age < 18 years

Pregnancy or active pregnancy wish

Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus

Recent valve intervention/surgery or acute myocardial infarction (< 6 months)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Left bundle branch area pacing

    Device

    Pacing of the left bundle branch area using a transvenous pacemaker lead

  • Biventricular pacing

    Device

    Pacing of the right and left ventricle using transvenous pacemaker leads

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Left bundle branch area pacingExperimental treatment 1 intervention
Group B: Biventricular pacingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Left ventricular end-systolic volume (LVESV) change

Left ventricular end-systolic volume change measured by echocardiography

Time frame
6 months

Secondary outcomes

1

Change in New York Heart Association functional class

Change in New York Heart Association functional class (NYHA)

Time frame
6 months
2

Change in Minnesota living with heart failure questionnaire

The Minnesota living with heart failure questionnaire (MLHFQ) is a self-administered disease-specific questionnaire for patients with heart failure, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of heart failure on quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst quality of life).

Time frame
6 months
3

Change in 6-minute walking distance

Change in 6-minute walking distance

Time frame
6 months
4

Change in QRS duration

Change in QRS duration on the 12-lead ECG

Time frame
6 months

Other outcomes

Sponsors and contacts

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

srdpiers

Lead sponsor

Leiden University Medical Center

Sponsor institution

Aarhus University Hospital

Collaborator

Source ClinicalTrials.gov
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