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Evaluation of Accelerated Bachmann Bundle Area Pacing in Heart Failure With Reduced ejectIon Fraction Who Have electrocarDioGraphic Evidence of Interatrial Block and Indicated for Implantable Cardioverter Defibrillator

ConditionHeart Failure and Reduced Ejection Fraction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeoul National University Hospital

About this trial

To evaluate the effect of accelerated atrial resynchronization achieved through Bachmann bundle pacing at the time of implantable cardioverter-defibrillator implantation in patients with heart failure with reduced ejection fraction and interatrial block

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years at the time of screening.

A documented diagnosis of chronic heart failure with New York Heart Association (NYHA) class II-IV.

Left ventricular ejection fraction (LVEF) ≤40%, documented by an imaging study performed within 12 months prior to screening.

Participants receiving ongoing treatment must be on a stable regimen for at least 1 month prior to screening (except for diuretics).

Disqualifiers

Non-paroxysmal AF.

Uncontrolled tachyarrhythmia.

Sinus bradycardia requiring continuous atrial pacing or atrioventricular block requiring ventricular pacing.

Acute decompensated heart failure at the time of screening or hospitalization for worsening heart failure within 4 weeks prior to enrollment.

Trial design

Design model

Crossover

Treatments tested in this trial

  • BBAP on

    Device

    ICD programmed for 6 weeks with LRL 70 beats/min, DDDR, and APP enabled.

  • BBAP off

    Device

    ICD programmed for 6 weeks with an LRL 30 beats/min in VVI mode

  • RAAP

    Drug

    ICD programmed for 6 weeks with LRL 70 beats/min, DDDR, and APP enabled.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: BBAP onExperimental treatment 1 intervention
Group B: BBAP offActive comparator 1 intervention
Group C: RAAP onOther 1 intervention

Trial outcomes

Primary outcomes

1

Relative change in NT-proBNP at 6 weeks (accelerated Bachmann bundle area pacing ON) compared with baseline (accelerated Bachmann bundle area pacing OFF).

Time frame
up to 6 weeks

Secondary outcomes

1

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 6 weeks, 16 weeks, and 12 months compared with baseline.

Time frame
up to 12 months
2

Changes in E and A wave velocity (m/s) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.

Time frame
up to 12 months
3

Changes in E/A and E/E' ratios on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.

Time frame
up to 12 months
4

Change in left atrial diameter (mm) on echocardiography at 6 weeks, 16 weeks, and 12 months compared with baseline.

Time frame
up to 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Seoul National University Hospital

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: