CRT In Narrow QRS Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Temporary pacing study; Radiation: Body Surface Mapping

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EF
    • Department of Cardiovascular Imaging, King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mechanical Dyssynchrony; Those with cardiac MRI evidence of mechanical dyssynchrony	Procedure: Temporary pacing study; Other Names: Electrophysiological study; Radiation: Body Surface Mapping; Other Names: ECG imaging
Active Comparator: No Mechanical Dyssynchrony; Those without mechanical dyssynchrony on cardiac MRI	Procedure: Temporary pacing study; Other Names: Electrophysiological study; Radiation: Body Surface Mapping; Other Names: ECG imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LV dP/dT during pacing	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.	during temporary pacing study, approximately 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of electrical and mechanical dyssynchrony	To correlate the amount of mechanical dyssynchrony seen prior to pacing with electrical dyssynchrony measures from non-contact mapping and body surface mapping	Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London
• Investigators: Principal Investigator: Aldo Rinaldi, MBBS MD FHRS, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 18, 2017
• Study Completion (Actual): August 18, 2017

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Heart Failure; Imaging; Cardiac Resynchronization Therapy; Pacing; Electrophysiology; Resynchronization
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: nQRS-CRT