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
  Purpose

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 Intervention Phase
Heart Failure
Other: Advanced Imaging Guided LV lead placement
Device: Standard LV lead placement
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Change in the proportion of CRT responders [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 270
Study Start Date: October 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 5, 2011
Last Updated: September 6, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on August 26, 2014