The His optimised pacing evaluated for heart failure trial

AV optimisation delivered with direct His bundle pacing, in patients with heart failure, long PR without left bundle branch block: A randomised multi-centre clinical outcome study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN86179285

Enrollment

160

Registered

2016-01-20

Start date

2015-12-22

Completion date

Unknown

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure Circulatory System Heart failure

Interventions

All patients will be implanted with a pacemaker or implantable cardioverter defibrillator with one of the leads positioned on the His bundle in order to obtain direct His-bundle capture. If it is not

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 or above 2. Ventricular Ejection Fraction (EF) < 35% 3. New York Heart Association (NYHA) class II-IV 4. PR interval =200ms 5. Narrow QRS duration (=140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm

Exclusion criteria

Exclusion criteria: 1. Permanent or persistent atrial fibrillation 2. Paroxysmal atrial fibrillation with history of sustained AF (more than 24 hours) in the 6 months prior to screening 3. Patients who are unable to perform cardiopulmonary exercise testing 4. Other serious medical condition with life expectancy of less than 1 year or if it is anticipated patients will require MRI scanning 5. Lack of capacity to consent 6. Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)

Design outcomes

Primary

Measure	Time frame
Exercise capacity is determined by measuring peak oxygen uptake (VO2) at baseline, 6 and 12 months.	—

Secondary

Measure	Time frame
1. Changes in B-type Naturietic Peptide (BNP) are measured at baseline, 6 and 12 months 2. Changes in Quality of Life Scores are measured at baseline, 6 and 12 months 3. Cost effectiveness analysis is completed at baseline, 6 and 12 months 4. Echocardiographic measurement of left ventricular function and remodeling is measured at baseline, 6 and 12 months 5. Fluoroscopy time during device insertion is measured 2 months pre-randomisation and during device insertion 6. Percentage pacing, arrhythmia burden, pacing threshols, R wave amplitude and lead impedance are measured at baseline, 6 and 12 months	—

Measure

Time frame

1. Changes in B-type Naturietic Peptide (BNP) are measured at baseline, 6 and 12 months 2. Changes in Quality of Life Scores are measured at baseline, 6 and 12 months 3. Cost effectiveness analysis is completed at baseline, 6 and 12 months 4. Echocardiographic measurement of left ventricular function and remodeling is measured at baseline, 6 and 12 months 5. Fluoroscopy time during device insertion is measured 2 months pre-randomisation and during device insertion 6. Percentage pacing, arrhythmia burden, pacing threshols, R wave amplitude and lead impedance are measured at baseline, 6 and 12 months

—

Countries

England, United Kingdom

Contacts

Public ContactMyril Mariveles

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026