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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
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 5, 2011
    Last Updated
    September 6, 2011
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
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    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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