Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy

NCT02748876 | Completed

• 1 other identifier: 113
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)

  7 months and 11 months

Secondary Outcomes (3)

• 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

Study Arms (2)

His-Ventricular (HV)-optimised

EXPERIMENTAL

His-Ventricular (HV) optimised atrioventricular delay

Other: His-Ventricular (HV) optimisation

Non-optimised

NO INTERVENTION

Standard atrioventricular delay

Interventions

His-Ventricular (HV) optimisation OTHER

Optimisation of atrioventricular pacing interval

His-Ventricular (HV)-optimised

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Castle Hill Hospital

Hull, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: September 29, 2016
• Primary Completion: April 28, 2017
• Study Completion: March 15, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)