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PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial

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ClinicalTrials.gov Identifier: NCT01429753
Recruitment Status : Unknown
Verified September 2011 by Manav Sohal, Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : September 7, 2011
Last Update Posted : September 7, 2011
Sponsor:
Information provided by (Responsible Party):
Manav Sohal, Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Advanced Imaging Guided LV lead placement Device: Standard LV lead placement Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2011
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Standard LV lead placement Device: Standard LV lead placement
Standard LV lead placement not guided by advanced imaging
Experimental: Advanced Imaging Guided LV Lead Placement 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.



Primary Outcome Measures :
  1. Change in the proportion of CRT responders [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in echo derived end systolic (ESV) and diastolic volumes [ Time Frame: 6 months ]
  2. Six month assessment of change in 6 minute walk distance and VO2 max (CPEX) [ Time Frame: 6 months ]
  3. Procedural success [ Time Frame: 0 months ]
  4. Procedure duration [ Time Frame: 0 months ]
  5. Radiation dose [ Time Frame: 0 months ]
  6. Contrast dose [ Time Frame: 0 months ]
  7. Procedural complications [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429753


Contacts
Contact: Manav Sohal, MBBS +442071887188 manav.sohal@gstt.nhs.uk

Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Christopher Aldo Rinaldi, MD Guy's and St Thomas' NHS Foundation Trust

Responsible Party: Manav Sohal, Clinical Research Fellow, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01429753     History of Changes
Other Study ID Numbers: 09/H0802/126
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by Manav Sohal, Guy's and St Thomas' NHS Foundation Trust:
Cardiac resychronisation therapy
Heart failure
Imaging guided LV lead placement

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases