Clinical trial NCT03258060: CRT In Narrow QRS Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Official title: Cardiac Resynchronisation Therapy In Patients With Narrow QRS Morphology And Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Pacing
Resynchronization
Electrophysiology
Imaging
Cardiac Resynchronization Therapy
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2017-08-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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). Also CRT has been seen to improve some heart failure patients with a normal electrical conduction (seen on the ECG as a narrow QRS complex). The investigators aim to see if cardiac MRI can be used to select patients with normal electrical conduction for CRT, therefore expanding the number of people who would stand to benefit from this treatment.


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.
  * NYHA grade III-IV heart failure
  * LVEF\<35%
  * 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.
  * Contraindication to an MRI scan
  * 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

Primary outcomes:
measure: LV dP/dT during pacing
timeFrame: during temporary pacing study, approximately 2 hours
Secondary outcomes:
measure: Correlation of electrical and mechanical dyssynchrony
timeFrame: Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Cardiovascular Imaging, King's College London
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Aldo Rinaldi, MBBS MD FHRS
role: PRINCIPAL_INVESTIGATOR
References: