PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Manav Sohal, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01429753
First received: September 5, 2011
Last updated: September 6, 2011
Last verified: September 2011

September 5, 2011
September 6, 2011
October 2011
April 2014   (final data collection date for primary outcome measure)
Change in the proportion of CRT responders [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01429753 on ClinicalTrials.gov Archive Site
  • Change in echo derived end systolic (ESV) and diastolic volumes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Six month assessment of change in 6 minute walk distance and VO2 max (CPEX) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Procedural success [ Time Frame: 0 months ] [ Designated as safety issue: No ]
  • Procedure duration [ Time Frame: 0 months ] [ Designated as safety issue: No ]
  • Radiation dose [ Time Frame: 0 months ] [ Designated as safety issue: Yes ]
  • Contrast dose [ Time Frame: 0 months ] [ Designated as safety issue: Yes ]
  • Procedural complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial
A Prospective Randomised Study of Advanced Imaging Guided Cardiac Resynchronisation Therapy (CRT) vs Conventional CRT Implantation in Patients With Chronic Heart Failure

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
  • Other: Advanced Imaging Guided LV lead placement
    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.
  • Device: Standard LV lead placement
    Standard LV lead placement not guided by advanced imaging
  • Active Comparator: Standard LV lead placement
    Intervention: Device: Standard LV lead placement
  • Experimental: Advanced Imaging Guided LV Lead Placement
    Intervention: Other: Advanced Imaging Guided LV lead placement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
270
April 2014
April 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Manav Sohal, MBBS +442071887188 manav.sohal@gstt.nhs.uk
Not Provided
 
NCT01429753
09/H0802/126
Yes
Manav Sohal, Guy's and St Thomas' NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
Not Provided
Principal Investigator: Christopher Aldo Rinaldi, MD Guy's and St Thomas' NHS Foundation Trust
Guy's and St Thomas' NHS Foundation Trust
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP