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Cardiac Resynchronisation Therapy In Patients With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322877
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 30, 2020
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). 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
Heart Failure 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: 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 Name: Electrophysiology study

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

Diagnostic Test: Invasive catheter-based mapping
Invasive electroanatomical mapping




Primary Outcome Measures :
  1. Improvement in LV dP/dTmax >10 percent during temporary multisite pacing [ Time Frame: Intra-procedure ]

Secondary Outcome Measures :
  1. Electrical dyssynchrony measured from electro-anatomical mapping [ Time Frame: Intra-procedure ]


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.
  • 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

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): NCT04322877


Contacts
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Contact: Christopher A Rinaldi, MBBS MD FHRS 02071889257 aldo.rinaldi@kcl.ac.uk

Locations
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United Kingdom
Guys and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Christopher A Rinaldi    02071889257    aldo.rinaldi@kcl.ac.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04322877    
Other Study ID Numbers: 125230
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases