PRISM Cardiac Resynchronisation Therapy (CRT) Randomised Controlled Trial

Heart Failure Clinical 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01429753
• Other study ID #: 09/H0802/126
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: September 5, 2011
• Last updated: September 6, 2011
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: September 2011
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Manav Sohal, MBBS
• Phone: +442071887188
• Email: manav.sohal[@]gstt.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the proportion of CRT responders		6 months	No
Secondary	Change in echo derived end systolic (ESV) and diastolic volumes		6 months	No
Secondary	Six month assessment of change in 6 minute walk distance and VO2 max (CPEX)		6 months	No
Secondary	Procedural success		0 months	No
Secondary	Procedure duration		0 months	No
Secondary	Radiation dose		0 months	Yes
Secondary	Contrast dose		0 months	Yes
Secondary	Procedural complications		6 months	Yes