Heart failure patients may benefit from having a special pacemaker implanted that can make the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in optimal positions. Only two thirds of people respond to CRT and this may be because of non-ideal pacing wire position. A potential marker for response is the change in heart pump pressure change over time. The aim of this study is to use a specialised wire in the main pumping chamber of the heart to record the pressure changes with the pacing lead in various positions to determine the optimal position. It is postulated that the improved pressure changes will increase the proportion of responders. Pilot study work has shown that the work is technically feasible and safe. The initial data has been published in a highly regarded scientific journal. This main study will be a multicentre randomised controlled trial whereby patients will be randomised to either standard treatment or pressure wireguided treatment. The patients in the pressurewire guided arm will have a specialised wire implanted into the main pumping chamber of their heart via a blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). This will measure acute pressure changes over time and the pacing lead will be positioned in the site that gives the greatest change in pressure. If the patients in the pressurewire guided arm fare better than those receiving standard treatment it may alter how a large proportion of heart failure patients are treated around the world. The study requires 282 patients and is likely to take two years to complete.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
282
A pressure wire will be sited in the left ventricle to measure dP/dT max. The LV lead position that gives the highest dP/dT max will be the final position used.
Hospital Auxolgico
Milan, Italy
RECRUITINGSan Rafaelle Hospital
Milan, Italy
RECRUITINGMedway Maritime Hospital
Gillingham, Kent, United Kingdom
RECRUITINGGuy's and St. Thomas' NHS Foundation NHS Trust
London, London, United Kingdom
RECRUITINGQueen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
RECRUITINGRoyal Bournemouth Hospital
Bournemouth, United Kingdom
RECRUITINGQueen Elizabeth Hospital Woolwich
London, United Kingdom
RECRUITINGThe Heart Hospital
London, United Kingdom
RECRUITINGFreeman Hospital
Newcastle upon Tyne, United Kingdom
RECRUITINGJohn Radcliffe Hospital
Oxford, United Kingdom
RECRUITINGChange in the proportion of CRT responders at 6 months
Time frame: 6 months
Change in clinical composite score at 6 months
Time frame: 6 months
Change in echo derived endsystolic volume (ESV) at six months
Time frame: 6 months
Change in echo derived enddiastolic colume (EDV) at six months
Time frame: 6 months
Change in echo derived left ventricular ejection fraction (LVEF) at 6 months
Time frame: 6 months
Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire)
Time frame: 6 months
Six month change in 6 minute walk distance
Time frame: 6 months
Six month change in VO2 max (CPET)
Time frame: 6 months
Six month change in ntProBNP
Time frame: 6 months
Six month difference in hospital readmission (days)
Time frame: 6 months
Six month difference in mortality
Time frame: 6 months
Difference in rates of successful LV lead implantation
Time frame: One week
Difference in procedure duration
Time frame: One week
Difference in radiation dose
Time frame: One week
Difference in contrast dose
Time frame: One week
Procedural complications
Time frame: 6 months
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