NCT03258060

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

3.4 years

First QC Date

March 17, 2014

Last Update Submit

August 18, 2017

Conditions

Heart Failure

Keywords

Heart FailurePacingResynchronizationElectrophysiologyImagingCardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Mechanical Dyssynchrony

ACTIVE COMPARATOR

Those with cardiac MRI evidence of mechanical dyssynchrony

Procedure: Temporary pacing studyRadiation: Body Surface Mapping

No Mechanical Dyssynchrony

ACTIVE COMPARATOR

Those without mechanical dyssynchrony on cardiac MRI

Procedure: Temporary pacing studyRadiation: Body Surface Mapping

Interventions

Temporary pacing studyPROCEDURE
Also known as: Electrophysiological study
Mechanical DyssynchronyNo Mechanical Dyssynchrony
Body Surface MappingRADIATION
Also known as: ECG imaging
Mechanical DyssynchronyNo Mechanical Dyssynchrony

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Imaging, King's College London

London, SE1 7EF, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Aldo Rinaldi, MBBS MD FHRS

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

August 23, 2017

Study Start

April 1, 2014

Primary Completion

August 18, 2017

Study Completion

August 18, 2017

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

GB(1)