- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322877
Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
March 26, 2020 updated by: Guy's and St Thomas' NHS Foundation Trust
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christopher A Rinaldi, MBBS MD FHRS
- Phone Number: 02071889257
- Email: aldo.rinaldi@kcl.ac.uk
Study Locations
-
-
-
London, United Kingdom, SE1 7EH
- Recruiting
- Guys and St Thomas' NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Body surface mapping and temporary pacing
Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.
|
Temporary delivery of CRT
Other Names:
As part of non-invasive mapping protocol
Measurement of invasive dP/dTmax
Cardioinsight body surface mapping
|
EXPERIMENTAL: Catheter-based mapping and temporary pacing
Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping.
|
Temporary delivery of CRT
Other Names:
Measurement of invasive dP/dTmax
Invasive electroanatomical mapping
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in LV dP/dTmax >10 percent during temporary multisite pacing
Time Frame: Intra-procedure
|
Intra-procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Electrical dyssynchrony measured from electro-anatomical mapping
Time Frame: Intra-procedure
|
Intra-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2019
Primary Completion (ANTICIPATED)
September 30, 2021
Study Completion (ANTICIPATED)
September 30, 2021
Study Registration Dates
First Submitted
March 24, 2020
First Submitted That Met QC Criteria
March 24, 2020
First Posted (ACTUAL)
March 26, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 30, 2020
Last Update Submitted That Met QC Criteria
March 26, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 125230
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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