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High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study

ConditionsCardiac Conduction SystemHis Bundle PacingHeart FailureCardiomyopathies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMiulli General Hospital

About this trial

Cardiac Resynchronization Therapy (CRT) decreases heart failure hospitalizations and mortality and increases left ventricular Ejection Fraction (EF) in patients with dilated cardiomyopathy, left bundle branch block and QRS duration \>130msec. His bundle pacing has a similar effect in this category of patients. However, CRT is not beneficial in heart failure (HF) patients with narrow QRS. His-bundle pacing delivers physiological ventricular activation and has been shown to improve acute hemodynamic function in patients with heart failure, a prolonged PR interval, and either a narrow QRS or RBBB through AV delay optimization. We observed an acute hemodynamic effect during application of higher pacing output (3.5 Volts/1 msec) in HF patients with dilated or ischemic cardiomyopathy and narrow QRS independently of the paced QRS duration or AV delay shortening.

This is a single-center, prospective randomized single-blinded study, recruiting a sub-population of patients with heart failure (dilated or ischemic cardiomyopathy, EF\<50%, narrow QRS (\<110 msec), in optimal medical treatment who have an indication for ICD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 or above

Ventricular Ejection Fraction (EF) < 50%; BNP needs to be ≥250ng/L or N Terminal-pro BNP≥600ng/L for patients with EF 36-50% and they should have an ICD indication

New York Heart Association (NYHA) class I-IV

Narrow QRS duration (≤110ms) on 12 lead ECG

Disqualifiers

Other serious medical condition with life expectancy of less than 1 year

Lack of capacity to consent

Pregnancy

Previous aortic valve surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Intensity His Bundle pacing

    Device

    All patients will be implanted with an Implantable cardioverter defibrillator (ICD) and an ICD lead in the right ventricle (either RV apex or RV septum). In all patients a pacing lead will be positioned in the right atrium (typically the right atrial appendage). All patients will have a pacemaker lead positioned on the His bundle to obtain direct His-bundle capture.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: High intensity His bundle pacingExperimental treatment 1 intervention
Group B: Back up only ventricular pacingSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in left ventricular ejection fraction

change in left ventricular ejection fraction measured by 2D echo at 6 months compared to baseline

Time frame
Baseline pre-intervention, randomisation and 6 months post randomisation

Secondary outcomes

1

Changes in B-type Natriuretic Peptide (BNP)

Measured from blood samples

Time frame
Baseline pre-intervention, randomisation and 6 months post randomisation
2

Changes in Quality of Life (QOL) Scores

Change in QOL measured by the Kansas City Cardiomyopathy Questionnaire at 1 and 6 months compared to baseline. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest

Time frame
Baseline pre-intervention,1 and 6 months post randomisation
3

Changes in arrhythmia burden

Measured during Pacemaker control

Time frame
1 month and 6 months post randomization.

Other outcomes

Sponsors and contacts

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

Miulli General Hospital

Lead sponsor

Source ClinicalTrials.gov
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