Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Rouen

About this trial

The objective of the study is to evaluate the functional benefit of left bundle branch of His pacing compared to right ventricular pacing in patients implanted with a pacemaker prior to a atrioventricular node ablation procedure for rapid atrial fibrillation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Impairment of autonomy such that a maximal cardiorespiratory effort test (VO2 Max test) cannot be performed under good conditions (ADL scale < 5).

LVEF < 40% at inclusion

Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or curatorship.

Patient participating in another interventional trial

Trial design

Design model

Crossover

Treatments tested in this trial

  • left bundle branch of His pacing

    Procedure/Surgery

    left bundle branch of His pacing

  • right ventricular pacing

    Procedure/Surgery

    right ventricular pacing

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)Experimental treatment 2 interventions
Group B: right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP)Experimental treatment 0 interventions

Trial outcomes

Primary outcomes

1

Maximum Oxygen Consumption (VO2 max) in mL/min/kg.

Time frame
18 months

Secondary outcomes

1

walking test distance covered

Time frame
18 months
2

echography criteria: LVEF (%), indexed left ventricular end-systolic volume (mL/m2), indexed cardiac output (L/min/m2), inter-ventricular asynchrony criteria (aortic pre-ejection time - pulmonary pre-ejection time)

Time frame
18 months
3

Determination of NT pro BNP or BNP

Time frame
18 months
4

Physical component of quality-of-life scale (SF-36)

Time frame
18 months

Other outcomes

Sponsors and contacts

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