Heart Failure
Conditions
Keywords
Heart Failure, Pacing, Resynchronization, Electrophysiology, Imaging, Cardiac Resynchronization Therapy
Brief summary
Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). Also CRT has been seen to improve some heart failure patients with a normal electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see if cardiac MRI can be used to select patients with normal electrical conduction for CRT, therefore expanding the number of people who would stand to benefit from this treatment.
Interventions
PROCEDURETemporary pacing study
RADIATIONBody Surface Mapping
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 years or above. * NYHA grade III-IV heart failure * LVEF\<35% * QRS duration \<120ms * On optimum medical therapy for heart failure * Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter * Able (in the Investigators opinion) and willing to comply with all study requirements. * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion criteria
* • Female participants who is pregnant, lactating or planning pregnancy during the course of the study. * Scheduled elective surgery or other procedures requiring general anaesthesia during the study. * Participant who is terminally ill or is inappropriate for placebo medication * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * Contraindication to an MRI scan * Rate uncontrolled atrial fibrillation precluding a cMR * Significant peripheral vascular disease precluding an EP study * A contraindication to anticoagulation * A prosthetic aortic or tricuspid valve * Significant Aortic valve disease * Known LV thrombus * Insufficient capacity to consent to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LV dP/dT during pacing | during temporary pacing study, approximately 2 hours | To assess LV dP/dT during different pacing modalities by intraventricular pressure wire. A dP/dT change of \>10% from baseline is a positive result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of electrical and mechanical dyssynchrony | Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months | To correlate the amount of mechanical dyssynchrony seen prior to pacing with electrical dyssynchrony measures from non-contact mapping and body surface mapping |
Countries
United Kingdom
Outcome results
None listed