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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Temporary pacing Study
Thoracic CT
Acute hemodynamic study
Non-invasive body surface mapping
Invasive catheter-based 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 treatment trial for Heart Failure

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.
  • 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

Sites / Locations

  • Guys and St Thomas' NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Body surface mapping and temporary pacing

Catheter-based mapping and temporary pacing

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in LV dP/dTmax >10 percent during temporary multisite pacing

Secondary Outcome Measures

Electrical dyssynchrony measured from electro-anatomical mapping

Full Information

First Posted
March 24, 2020
Last Updated
March 26, 2020
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
NCT04322877
Brief Title
Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Official Title
Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

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

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Body surface mapping and temporary pacing
Arm Type
Experimental
Arm Description
Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.
Arm Title
Catheter-based mapping and temporary pacing
Arm Type
Experimental
Arm Description
Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping.
Intervention Type
Procedure
Intervention Name(s)
Temporary pacing Study
Other Intervention Name(s)
Electrophysiology study
Intervention Description
Temporary delivery of CRT
Intervention Type
Radiation
Intervention Name(s)
Thoracic CT
Intervention Description
As part of non-invasive mapping protocol
Intervention Type
Diagnostic Test
Intervention Name(s)
Acute hemodynamic study
Intervention Description
Measurement of invasive dP/dTmax
Intervention Type
Diagnostic Test
Intervention Name(s)
Non-invasive body surface mapping
Intervention Description
Cardioinsight body surface mapping
Intervention Type
Diagnostic Test
Intervention Name(s)
Invasive catheter-based mapping
Intervention Description
Invasive electroanatomical mapping
Primary Outcome Measure Information:
Title
Improvement in LV dP/dTmax >10 percent during temporary multisite pacing
Time Frame
Intra-procedure
Secondary Outcome Measure Information:
Title
Electrical dyssynchrony measured from electro-anatomical mapping
Time Frame
Intra-procedure

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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher A Rinaldi, MBBS MD FHRS
Phone
02071889257
Email
aldo.rinaldi@kcl.ac.uk
Facility Information:
Facility Name
Guys and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher A Rinaldi
Phone
02071889257
Email
aldo.rinaldi@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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