Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
282 participants
INTERVENTIONAL
2012-09-30
2018-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard CRT Implant
Standard CRT Implant
Pressure-wire guided CRT Implant
Pressure-wire guided CRT implant
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.
Interventions
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Standard CRT Implant
Pressure-wire guided CRT implant
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
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Inclusion Criteria
* Ischaemic or non-ischaemic heart failure
Exclusion Criteria
* Severe aortic valve disease
* Mechanical aortic valve replacement
* Severe peripheral vascular disease
* LV thrombus
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Manav Sohal
Research Fellow
Locations
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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, 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
Countries
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Central Contacts
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Facility Contacts
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Giovanni Prerego, MD
Role: primary
Nicoleta Sora, MD
Role: primary
Shaumik Adhya, MBBS
Role: primary
Francisco Leyva, MD
Role: primary
John Paisey
Role: primary
Shoaib Hamid, MD
Role: primary
Pier Lambiase, MD
Role: primary
Janet McCoomb, MD
Role: primary
Tim Betts, MD
Role: primary
Other Identifiers
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11/LO/1879
Identifier Type: -
Identifier Source: org_study_id
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