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

Not Applicable

• Conditions: Heart Failure
• Interventions: Procedure: Temporary pacing Study; Radiation: Thoracic CT; Diagnostic Test: Acute hemodynamic study; Diagnostic Test: Invasive catheter-based mapping; Diagnostic Test: Non-invasive body surface mapping

• Registration Number: NCT04322877
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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). 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Body surface mapping and temporary pacing	Thoracic CT	Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.
Catheter-based mapping and temporary pacing	Acute hemodynamic study	Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping.
Catheter-based mapping and temporary pacing	Invasive catheter-based mapping	Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping.
Body surface mapping and temporary pacing	Acute hemodynamic study	Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.
Body surface mapping and temporary pacing	Non-invasive body surface mapping	Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.
Body surface mapping and temporary pacing	Temporary pacing Study	Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.
Catheter-based mapping and temporary pacing	Temporary pacing Study	Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping.

Primary Outcome Measures

Name	Time	Method
Improvement in LV dP/dTmax >10 percent during temporary multisite pacing	Intra-procedure

Secondary Outcome Measures

Name	Time	Method
Electrical dyssynchrony measured from electro-anatomical mapping	Intra-procedure

Trial Locations

Locations (1)

Guys and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom