Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- Change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP) [ Time Frame: 7 months and 11 months ]
- Increase in 6-min walk test distance by ≥25 m [ Time Frame: 7 months and 11 months ]
- ≥5points improvement in the short Kansas City Cardiomyopathy Questionnaire score [ Time Frame: 7 months and 11 months ]
- Reduction of left ventricular end-diastolic volume. [ Time Frame: 7 months and 11 months ]