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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258060
Recruitment Status : Terminated (release of other trial indicating futility of this study after recruitment of 1 patient)
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
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). 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.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Temporary pacing study Radiation: Body Surface Mapping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Resynchronisation Therapy In Patients With Narrow QRS Morphology And Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Study Start Date : April 2014
Actual Primary Completion Date : August 18, 2017
Actual Study Completion Date : August 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Mechanical Dyssynchrony
Those with cardiac MRI evidence of mechanical dyssynchrony
Procedure: Temporary pacing study
Other Name: Electrophysiological study

Radiation: Body Surface Mapping
Other Name: ECG imaging

Active Comparator: No Mechanical Dyssynchrony
Those without mechanical dyssynchrony on cardiac MRI
Procedure: Temporary pacing study
Other Name: Electrophysiological study

Radiation: Body Surface Mapping
Other Name: ECG imaging




Primary Outcome Measures :
  1. LV dP/dT during pacing [ Time Frame: during temporary pacing study, approximately 2 hours ]
    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 :
  1. Correlation of electrical and mechanical dyssynchrony [ 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 ]
    To correlate the amount of mechanical dyssynchrony seen prior to pacing with electrical dyssynchrony measures from non-contact mapping and body surface mapping



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258060


Locations
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United Kingdom
Department of Cardiovascular Imaging, King's College London
London, United Kingdom, SE1 7EF
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Investigators
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Principal Investigator: Aldo Rinaldi, MBBS MD FHRS Guy's and St Thomas' NHS Foundation Trust
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03258060    
Other Study ID Numbers: nQRS-CRT
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Heart Failure
Pacing
Resynchronization
Electrophysiology
Imaging
Cardiac Resynchronization Therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases