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

Sponsor

Hull University Teaching Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02748876

Collaborator

(none)

Enrollment

Location

Arms

17.5

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: His-Ventricular (HV) optimisation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomised Cross-over Pilot Study of the Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy

Actual Study Start Date :

Sep 29, 2016

Actual Primary Completion Date :

Apr 28, 2017

Actual Study Completion Date :

Mar 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: His-Ventricular (HV)-optimised His-Ventricular (HV) optimised atrioventricular delay	Other: His-Ventricular (HV) optimisation Optimisation of atrioventricular pacing interval
No Intervention: Non-optimised Standard atrioventricular delay

Arm

Intervention/Treatment

Experimental: His-Ventricular (HV)-optimised

His-Ventricular (HV) optimised atrioventricular delay

Other: His-Ventricular (HV) optimisation

Optimisation of atrioventricular pacing interval

No Intervention: Non-optimised

Standard atrioventricular delay

Outcome Measures

Primary Outcome Measures

Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP) [7 months and 11 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Castle Hill Hospital	Hull		United Kingdom

Sponsors and Collaborators

Hull University Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hull University Teaching Hospitals NHS Trust

ClinicalTrials.gov Identifier:

NCT02748876

Other Study ID Numbers:

First Posted:

Apr 22, 2016

Last Update Posted:

Jul 17, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jul 17, 2019