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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748876
• Other study ID #: 113
• Status: Completed
• Phase: N/A
• Start date: September 29, 2016
• Est. completion date: March 15, 2018

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 15, 2018
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• His-Ventricular (HV) optimisation
Optimisation of atrioventricular pacing interval

Locations

Country	Name	City	State
United Kingdom	Castle Hill Hospital	Hull

Sponsors (1)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP)		7 months and 11 months
Secondary	Increase in 6-min walk test distance by =25 m		7 months and 11 months
Secondary	=5points improvement in the short Kansas City Cardiomyopathy Questionnaire score		7 months and 11 months
Secondary	Reduction of left ventricular end-diastolic volume.		7 months and 11 months