Pressure Wire Guided Cardiac Resynchronisation Therapy
A Prospective Randomised Controlled Trial of Cardiac Resynchronisation Therapy Guided by Invasive dP/dT: Radi-CRT Study
1 other identifier
interventional
282
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 heart-failure
Started Sep 2012
Longer than P75 for phase_2 heart-failure
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2011
CompletedFirst Posted
Study publicly available on registry
November 3, 2011
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 4, 2017
April 1, 2017
5.6 years
October 31, 2011
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in the proportion of CRT responders at 6 months
6 months
Change in clinical composite score at 6 months
6 months
Secondary Outcomes (14)
Change in echo derived endsystolic volume (ESV) at six months
6 months
Change in echo derived enddiastolic colume (EDV) at six months
6 months
Change in echo derived left ventricular ejection fraction (LVEF) at 6 months
6 months
Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire)
6 months
Six month change in 6 minute walk distance
6 months
- +9 more secondary outcomes
Study Arms (2)
Standard CRT Implant
ACTIVE COMPARATORPressure-wire guided CRT Implant
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients fulfilling standard criteria for CRT
- Ischaemic or non-ischaemic heart failure
You may not qualify if:
- Contraindication to pressure wire assessment including:
- Severe aortic valve disease
- Mechanical aortic valve replacement
- Severe peripheral vascular disease
- LV thrombus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guy's and St Thomas' NHS Foundation Trustlead
- Abbott Medical Devicescollaborator
Study Sites (10)
Hospital Auxolgico
Milan, Italy
San Rafaelle Hospital
Milan, Italy
Medway Maritime Hospital
Gillingham, Kent, United Kingdom
Guy's and St. Thomas' NHS Foundation NHS Trust
London, London, SE1 7EH, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Queen Elizabeth Hospital Woolwich
London, United Kingdom
The Heart Hospital
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Fellow
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 3, 2011
Study Start
September 1, 2012
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 4, 2017
Record last verified: 2017-04