PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial
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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 |
- Change in the proportion of CRT responders [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Manav Sohal, MBBS | +442071887188 | manav.sohal@gstt.nhs.uk |
| 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 May 16, 2013