A Phase 3 interventional study of Cardiac Resynchronisation Therapy in Heart Failure, sponsored by Guy's and St Thomas' NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-01.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Phase 3, Interventional, and Treatment
100 pt multicentre study 50 pts randomised to triventricular pacemaker, 50 to biventricular pacemaker Feasibility study with 6 month outcome data
100 patients with QRS duration (120-150ms LBBB) for device insertion as per ESC guidelines 2013 will be recruited to the study from 10 centres. Patients will undergo the pre-operative work up that is typical of their institution (for example at the GSTT site this will include cardiac MRI, cardiopulmonary exercise testing (CPET), 6 minute walk test , bloods including Nt pro BNP, Minnesota living with heart failure questionnaire (MLWHFQ), 2D/3D echocardiogram and the collection of demographic data.)
Patients will then be randomised in a 1:1 fashion to receive either the Triventricular device or the conventional biventricular device.
Participants will then be followed up as per the implanting institution's typical follow up. (for example at GSTT this will include 6 week atrio-ventricular and ventricular-ventricular optimisation (if patients have a device that does not autooptimise) and review by a clinician as well as a 6 month follow up at which point the CPET, 6 minute walk test , MLWHFQ, bloods including Nt pro BNP, 2D/3D echocardiogram and the collection of demographic data will be repeated.)
Regardless of the institution's own follow up, a 6 week (4-8 week) and 6 month (5-9month) follow up appointment will form part of the study protocol. The 6 week check will be take the form of a standard clinical pacing check with physician input if it is deemed necessary as per the host institution's usual standard of care/ (usually one would imagine if a problem of therapy delivery is noted)
The 6 month follow up will allow for patient and device follow up. This will require 2D echocardiography, 6 min walk test, MLWHFQ and NtproBNP measurement. Where possible institutions will be encouraged to perform CPET and 3D echocardiography pre implant and at 6 months.
For determining the " response rate", a positive response will be defined as an absolute reduction of LVESV by 15%. In order to determine the magnitude of response then the change in LVESV will be assessed as a continuous variable.
5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 Left ventricular leads and one right ventricular lead
Procedure: Cardiac Resynchronisation Therapy
1 left ventricular lead and one right ventricular lead
Procedure: Cardiac Resynchronisation Therapy
Also known as: Cardiac Resynchronisation Therapy with Defibrillator
Feasibility of achieving and maintaining triventricular pacing at 6 months
Percentage of patients having triventricular pacing at 6 months
Time frame: 6 months
Proportion of patients who successfully reverse remodel as per echo (success being defined as a reduction in end systolic volume of > 15%
outcome
Time frame: 6 months
Proportionate effect of intervention and comparator with regard to reverse remodelling (comparison of % reduction in left ventricular end systolic volume )
outcome
Time frame: 6 months
Proportion of patients who successfully reverse remodel as per echo (success being defined as a reduction in end systolic volume of > 15% with prespecified subgroups (AF and aetiology)
6 months
Time frame: 6 months
Proportionate effect of intervention and comparator with regard to reverse remodelling (comparison of % reduction in left ventricular end systolic volume ) (AF and aetiology)
outcome
Time frame: 6 months
Mean change in Nt proBNP in patients with triventricular devices compared with biventricular devices (pg/ml)
outcome
Time frame: 6 months
Comparison of effect of biventricular and triventricular pacing on scores in the Minnesota Living with Heart Failure Questionnaire
outcome
Time frame: 6 months
Comparison of effect of biventricular and triventricular pacing on change in 6 minute walk test (metres)
outcome
Time frame: 6 months
Percentage change in Nt proBNP in patients with triventricular devices compared with biventricular devices
outcome
Time frame: 6 months
Comparison of percentage of shocks delivered in triventricular arm vs biventricular arm
outcome
Time frame: 6 months
This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust