Clinical trial NCT01464502: Pressure Wire Guided Cardiac Resynchronisation Therapy
Official title: A Prospective Randomised Controlled Trial of Cardiac Resynchronisation Therapy Guided by Invasive dP/dT: Radi-CRT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: Heart failure
Cardiac resynchronisation therapy
Acute haemodynamic response
Responder
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2011-11-03
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients fulfilling standard criteria for CRT
* Ischaemic or non-ischaemic heart failure

Exclusion Criteria:

* Contraindication to pressure wire assessment including:
* Severe aortic valve disease
* Mechanical aortic valve replacement
* Severe peripheral vascular disease
* LV thrombus

Primary outcomes:
measure: Change in the proportion of CRT responders at 6 months
timeFrame: 6 months
measure: Change in clinical composite score at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in echo derived endsystolic volume (ESV) at six months
timeFrame: 6 months
measure: Change in echo derived enddiastolic colume (EDV) at six months
timeFrame: 6 months
measure: Change in echo derived left ventricular ejection fraction (LVEF) at 6 months
timeFrame: 6 months
measure: Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire)
timeFrame: 6 months
measure: Six month change in 6 minute walk distance
timeFrame: 6 months
measure: Six month change in VO2 max (CPET)
timeFrame: 6 months
measure: Six month change in ntProBNP
timeFrame: 6 months
measure: Six month difference in hospital readmission (days)
timeFrame: 6 months
measure: Six month difference in mortality
timeFrame: 6 months
measure: Difference in rates of successful LV lead implantation
timeFrame: One week
measure: Difference in procedure duration
timeFrame: One week
measure: Difference in radiation dose
timeFrame: One week
measure: Difference in contrast dose
timeFrame: One week
measure: Procedural complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Hospital Auxolgico
city: Milan
country: Italy
facility: San Rafaelle Hospital
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
state: Kent
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation NHS Trust
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital Woolwich
city: London
country: United Kingdom
facility: The Heart Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
References: