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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01429753

Enrollment

270

Registered

2011-09-07

Start date

2011-10-31

Completion date

2014-04-30

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac resychronisation therapy, Heart failure, Imaging guided LV lead placement

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.

Interventions

OTHERAdvanced 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.

DEVICEStandard LV lead placement

Standard LV lead placement not guided by advanced imaging

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Change in the proportion of CRT responders	6 months

Secondary

Measure	Time frame
Six month assessment of change in 6 minute walk distance and VO2 max (CPEX)	6 months
Procedural success	0 months
Procedure duration	0 months
Change in echo derived end systolic (ESV) and diastolic volumes	6 months
Contrast dose	0 months
Procedural complications	6 months
Radiation dose	0 months

Contacts

Primary ContactManav Sohal, MBBS

manav.sohal@gstt.nhs.uk+442071887188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026