Pressure Wire Guided Cardiac Resynchronisation Therapy
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Standard CRT Implant
Pressure-wire guided CRT implant
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Cardiac resynchronisation therapy, Acute haemodynamic response, Responder
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
Sites / Locations
- Hospital AuxolgicoRecruiting
- San Rafaelle HospitalRecruiting
- Medway Maritime HospitalRecruiting
- Queen Elizabeth Hospital BirminghamRecruiting
- Royal Bournemouth HospitalRecruiting
- Guy's and St. Thomas' NHS Foundation NHS TrustRecruiting
- Queen Elizabeth Hospital WoolwichRecruiting
- The Heart HospitalRecruiting
- Freeman HospitalRecruiting
- John Radcliffe HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard CRT Implant
Pressure-wire guided CRT Implant
Arm Description
Outcomes
Primary Outcome Measures
Change in the proportion of CRT responders at 6 months
Change in clinical composite score at 6 months
Secondary Outcome Measures
Change in echo derived endsystolic volume (ESV) at six months
Change in echo derived enddiastolic colume (EDV) at six months
Change in echo derived left ventricular ejection fraction (LVEF) at 6 months
Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire)
Six month change in 6 minute walk distance
Six month change in VO2 max (CPET)
Six month change in ntProBNP
Six month difference in hospital readmission (days)
Six month difference in mortality
Difference in rates of successful LV lead implantation
Difference in procedure duration
Difference in radiation dose
Difference in contrast dose
Procedural complications
Full Information
NCT ID
NCT01464502
First Posted
October 31, 2011
Last Updated
April 3, 2017
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT01464502
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Cardiac resynchronisation therapy, Acute haemodynamic response, Responder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard CRT Implant
Arm Type
Active Comparator
Arm Title
Pressure-wire guided CRT Implant
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Standard CRT Implant
Intervention Type
Procedure
Intervention Name(s)
Pressure-wire guided CRT implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the proportion of CRT responders at 6 months
Time Frame
6 months
Title
Change in clinical composite score at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in echo derived endsystolic volume (ESV) at six months
Time Frame
6 months
Title
Change in echo derived enddiastolic colume (EDV) at six months
Time Frame
6 months
Title
Change in echo derived left ventricular ejection fraction (LVEF) at 6 months
Time Frame
6 months
Title
Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire)
Time Frame
6 months
Title
Six month change in 6 minute walk distance
Time Frame
6 months
Title
Six month change in VO2 max (CPET)
Time Frame
6 months
Title
Six month change in ntProBNP
Time Frame
6 months
Title
Six month difference in hospital readmission (days)
Time Frame
6 months
Title
Six month difference in mortality
Time Frame
6 months
Title
Difference in rates of successful LV lead implantation
Time Frame
One week
Title
Difference in procedure duration
Time Frame
One week
Title
Difference in radiation dose
Time Frame
One week
Title
Difference in contrast dose
Time Frame
One week
Title
Procedural complications
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manav Sohal, BSc, MBBS
Phone
00447939061486
Email
manav.sohal@gstt.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Aldo Rinaldi, MBBS, MD
Email
aldo.rinaldi@gstt.nhs.uk
Facility Information:
Facility Name
Hospital Auxolgico
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Prerego, MD
Facility Name
San Rafaelle Hospital
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicoleta Sora, MD
Facility Name
Medway Maritime Hospital
City
Gillingham
State/Province
Kent
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaumik Adhya, MBBS
Facility Name
Queen Elizabeth Hospital Birmingham
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Leyva, MD
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Paisey
Facility Name
Guy's and St. Thomas' NHS Foundation NHS Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manav Sohal, BSc, MBBS
Phone
00447939061486
Email
manav.sohal@gstt.nhs.uk
First Name & Middle Initial & Last Name & Degree
Manav Sohal, BSc, MBBS
Facility Name
Queen Elizabeth Hospital Woolwich
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoaib Hamid, MD
Facility Name
The Heart Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pier Lambiase, MD
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet McCoomb, MD
Facility Name
John Radcliffe Hospital
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Betts, MD
12. IPD Sharing Statement
Learn more about this trial
Pressure Wire Guided Cardiac Resynchronisation Therapy
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