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
About this trial
This is an interventional treatment trial for Heart Failure
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
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
NCT ID
NCT04322877
First Posted
March 24, 2020
Last Updated
March 26, 2020
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
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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