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Completed

NCT Number: NCT02748876

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Castle Hill Hospital

Hull, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

His-Ventricular (HV) optimisation

Other

Optimisation of atrioventricular pacing interval

Primary outcomes

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

    Time frame: 7 months and 11 months

Secondary outcomes

  1. Increase in 6-min walk test distance by ≥25 m

    Time frame: 7 months and 11 months

  2. ≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score

    Time frame: 7 months and 11 months

  3. Reduction of left ventricular end-diastolic volume.

    Time frame: 7 months and 11 months

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 22, 2016
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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