A Randomised Cross-over Pilot Study of the Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
Study Overview
Brief Summary
Cardiac resynchronisation therapy (CRT) is a specialised type of pacemaker used in patients with severe heart failure to improve symptoms and survival. Approximately one third of patients treated with CRT do not notice significant improvement in their symptoms and this may be due to inadequate co-ordination between the upper and lower chambers of the heart (atrioventricular dyssynchrony).
The investigators propose a new method to achieve atrioventricular synchrony in CRT based on measurements of electrical conduction from within the heart. Patients referred for CRT implantation at Castle Hill Hospital are eligible to participate. During CRT implantation, additional measurements, will be recorded from within the heart. After implantation, device settings will be adjusted to either standard or electrophysiologically-optimised settings with cross-over at 4 months.
The investigators hypothesis is that patients with optimised settings will derive additional benefit compared to patients with standard pacemaker-determined settings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of heart failure
- •Referred for cardiac resynchronisation therapy (CRT) with or without defibrillator
- •In sinus rhythm
- •Patients must have a telephone
- •Ability to give informed consent
- •Ability to complete the study
Exclusion Criteria
- •Severe valve disease or previous valve replacement
- •Previous atrial flutter ablation
- •Chronic kidney disease Stage 3 or above
- •Recent myocardial infarction
- •Ongoing cardiac ischaemia
- •Infiltrative cardiomyopathy
- •Wolff-Parkinson White syndrome
- •Presence of second or third degree heart block
- •<90% biventricular pacing at 3 months
- •Hypertrophic cardiomyopathy
- •Pregnancy or breastfeeding
- •On treatment for hypothyroidism or hyperthyroidism
Arms & Interventions
Non-optimised
Standard atrioventricular delay
His-Ventricular (HV)-optimised
His-Ventricular (HV) optimised atrioventricular delay
Intervention: His-Ventricular (HV) optimisation (Other)
Outcomes
Primary Outcomes
Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time Frame: 7 months and 11 months
Secondary Outcomes
- Increase in 6-min walk test distance by ≥25 m(7 months and 11 months)
- ≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score(7 months and 11 months)
- Reduction of left ventricular end-diastolic volume.(7 months and 11 months)