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

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT04322877
Collaborator
King's College London (Other)
30
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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). 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Temporary pacing Study
  • Radiation: Thoracic CT
  • Diagnostic Test: Acute hemodynamic study
  • Diagnostic Test: Non-invasive body surface mapping
  • Diagnostic Test: Invasive catheter-based mapping
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Body surface mapping and temporary pacing

Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.

Procedure: Temporary pacing Study
Temporary delivery of CRT
Other Names:
  • Electrophysiology study

    • Radiation: Thoracic CT
    As part of non-invasive mapping protocol

    Diagnostic Test: Acute hemodynamic study
    Measurement of invasive dP/dTmax

    Diagnostic Test: Non-invasive body surface mapping
    Cardioinsight body surface mapping
    Experimental: Catheter-based mapping and temporary pacing

    Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping.

    Procedure: Temporary pacing Study
    Temporary delivery of CRT
    Other Names:
  • Electrophysiology study

    • Diagnostic Test: Acute hemodynamic study
    Measurement of invasive dP/dTmax

    Diagnostic Test: Invasive catheter-based mapping
    Invasive electroanatomical mapping

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in LV dP/dTmax >10 percent during temporary multisite pacing [Intra-procedure]

    Secondary Outcome Measures

    1. Electrical dyssynchrony measured from electro-anatomical mapping [Intra-procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guys and St Thomas' NHS Foundation Trust London United Kingdom SE1 7EH

    Sponsors and Collaborators

    • Guy's and St Thomas' NHS Foundation Trust
    • King's College London

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy's and St Thomas' NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT04322877
    Other Study ID Numbers:
    • 125230
    First Posted:
    Mar 26, 2020
    Last Update Posted:
    Mar 30, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Mar 30, 2020