Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping

Guy's and St Thomas' NHS Foundation Trust

Status: Unknown

Conditions: Heart Failure

Treatments: Diagnostic Test: Acute hemodynamic study; Radiation: Thoracic CT; Diagnostic Test: Non-invasive body surface mapping; Diagnostic Test: Invasive catheter-based mapping; Procedure: Temporary pacing Study

Study type: Interventional

Funder types: Other

Identifiers

NCT04322877

125230

Details and patient eligibility

About

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). The investigators aim to assess acute response to CRT and compare different methods of delivering CRT using hemodynamic data from invasive dP/dTmax and electroanatomical data from either invasive mapping or non-invasive body surface mapping.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Either 1) has CRT system in situ or 2) has a planned CRT system implant or 3) has a planned upgrade to CRT from a standard pacemaker
• NYHA grade II-IV heart failure
• LVEF<35%
• Intrinsic 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.
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Body surface mapping and temporary pacing

Experimental group

Description:

Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.

Treatment:

Diagnostic Test: Acute hemodynamic study

Radiation: Thoracic CT

Diagnostic Test: Non-invasive body surface mapping

Procedure: Temporary pacing Study

Catheter-based mapping and temporary pacing

Experimental group

Description:

Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping.

Treatment:

Diagnostic Test: Acute hemodynamic study

Procedure: Temporary pacing Study

Diagnostic Test: Invasive catheter-based mapping