PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Advanced Imaging Guided LV lead placement
Standard LV lead placement
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Cardiac resychronisation therapy, Heart failure, Imaging guided LV lead placement
Eligibility Criteria
Inclusion Criteria:
- >18yrs of age
- Standard indication for CRT=P or CRT=D according to NICE criteria (Clinical symptoms of heart failure despite medical therapy, broad QRS >120ms and significant LV dysfunction LEF <35%)
- Stable on optimal medical therapy for at least 3 months
- No exclusion to pacing /ICD
- Ischaemic or non-ischaemic aetiology
Exclusion Criteria:
- Any contraindication to pacing /ICD implant
- Contraindication to MR scanning
- Claustrophobia
- Significant renal impairment (estimated GFR <30)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard LV lead placement
Advanced Imaging Guided LV Lead Placement
Arm Description
Outcomes
Primary Outcome Measures
Change in the proportion of CRT responders
Secondary Outcome Measures
Change in echo derived end systolic (ESV) and diastolic volumes
Six month assessment of change in 6 minute walk distance and VO2 max (CPEX)
Procedural success
Procedure duration
Radiation dose
Contrast dose
Procedural complications
Full Information
NCT ID
NCT01429753
First Posted
September 5, 2011
Last Updated
September 6, 2011
Sponsor
Guy's and St Thomas' NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01429753
Brief Title
PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial
Official Title
A Prospective Randomised Study of Advanced Imaging Guided Cardiac Resynchronisation Therapy (CRT) vs Conventional CRT Implantation in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to improve LV function in patients with heart failure if those regions of the myocardium which are most compromised by electromechanical dyssynchrony can be identified and effectively stimulated. There still remains, however, a significant rate of up to 30% of patients who do not respond to treatment. Reasons for lack of benefit can be related to the inability of identifying and effectively stimulating those regions of myocardium, which are most compromised by electromechanical dyssynchrony. The investigators hypothesize that by using cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine the site of latest LV activation, the investigators can find the best place to implant the left ventricular lead. By avoiding scar and pacing in the site of latest activation, the investigators believe the investigators will reduce dyssynchrony and thus improve overall heart function. The researchers thus aim to increase the proportion of people who respond to treatment. The researchers also believe that the procedure may be streamlined so as to reduce procedure duration, radiation dose and dose of iodinated contrast medium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac resychronisation therapy, Heart failure, Imaging guided LV lead placement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard LV lead placement
Arm Type
Active Comparator
Arm Title
Advanced Imaging Guided LV Lead Placement
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Advanced Imaging Guided LV lead placement
Intervention Description
Use of MRI to identify scar and latest activating LV segment as well as CS anatomy. This will be used to guide LV lead placement real-time.
Intervention Type
Device
Intervention Name(s)
Standard LV lead placement
Intervention Description
Standard LV lead placement not guided by advanced imaging
Primary Outcome Measure Information:
Title
Change in the proportion of CRT responders
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in echo derived end systolic (ESV) and diastolic volumes
Time Frame
6 months
Title
Six month assessment of change in 6 minute walk distance and VO2 max (CPEX)
Time Frame
6 months
Title
Procedural success
Time Frame
0 months
Title
Procedure duration
Time Frame
0 months
Title
Radiation dose
Time Frame
0 months
Title
Contrast dose
Time Frame
0 months
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:
>18yrs of age
Standard indication for CRT=P or CRT=D according to NICE criteria (Clinical symptoms of heart failure despite medical therapy, broad QRS >120ms and significant LV dysfunction LEF <35%)
Stable on optimal medical therapy for at least 3 months
No exclusion to pacing /ICD
Ischaemic or non-ischaemic aetiology
Exclusion Criteria:
Any contraindication to pacing /ICD implant
Contraindication to MR scanning
Claustrophobia
Significant renal impairment (estimated GFR <30)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manav Sohal, MBBS
Phone
+442071887188
Email
manav.sohal@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Aldo Rinaldi, MD
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial
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