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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Temporary pacing study
Body Surface Mapping
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Heart Failure, Pacing, Resynchronization, Electrophysiology, Imaging, Cardiac Resynchronization Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
    • 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

Sites / Locations

  • Department of Cardiovascular Imaging, King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mechanical Dyssynchrony

No Mechanical Dyssynchrony

Arm Description

Those with cardiac MRI evidence of mechanical dyssynchrony

Those without mechanical dyssynchrony on cardiac MRI

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2014
Last Updated
August 18, 2017
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT03258060
Brief Title
CRT In Narrow QRS Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Official Title
Cardiac Resynchronisation Therapy In Patients With Narrow QRS Morphology And Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
release of other trial indicating futility of this study after recruitment of 1 patient
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 18, 2017 (Actual)
Study Completion Date
August 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Pacing, Resynchronization, Electrophysiology, Imaging, Cardiac Resynchronization Therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mechanical Dyssynchrony
Arm Type
Active Comparator
Arm Description
Those with cardiac MRI evidence of mechanical dyssynchrony
Arm Title
No Mechanical Dyssynchrony
Arm Type
Active Comparator
Arm Description
Those without mechanical dyssynchrony on cardiac MRI
Intervention Type
Procedure
Intervention Name(s)
Temporary pacing study
Other Intervention Name(s)
Electrophysiological study
Intervention Type
Radiation
Intervention Name(s)
Body Surface Mapping
Other Intervention Name(s)
ECG imaging
Primary Outcome Measure Information:
Title
LV dP/dT during pacing
Description
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.
Time Frame
during temporary pacing study, approximately 2 hours
Secondary Outcome Measure Information:
Title
Correlation of electrical and mechanical dyssynchrony
Description
To correlate the amount of mechanical dyssynchrony seen prior to pacing with electrical dyssynchrony measures from non-contact mapping and body surface mapping
Time Frame
Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Rinaldi, MBBS MD FHRS
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiovascular Imaging, King's College London
City
London
ZIP/Postal Code
SE1 7EF
Country
United Kingdom

12. IPD Sharing Statement

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

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