Status:
UNKNOWN
Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04322877
Start Date
September 1 2019
End Date
September 30 2021
Last Update
March 30 2020
Active Locations (1)
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1
Guys and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH