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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02748876
Recruitment Status : Unknown
Verified April 2016 by Hull and East Yorkshire Hospitals NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : April 22, 2016
Last Update Posted : April 26, 2016
Information provided by (Responsible Party):
Hull and East Yorkshire Hospitals NHS Trust

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Study Start Date : August 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

Primary Outcome Measures :
  1. Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP) [ Time Frame: 7 months and 11 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

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Responsible Party: Hull and East Yorkshire Hospitals NHS Trust Identifier: NCT02748876     History of Changes
Other Study ID Numbers: 113
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases