CRT In Narrow QRS Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping

Guy's and St Thomas' NHS Foundation Trust

Status: Terminated

Conditions: Heart Failure

Treatments: Radiation: Body Surface Mapping; Procedure: Temporary pacing study

Study type: Interventional

Funder types: Other

Identifiers

NCT03258060

nQRS-CRT

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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.
  • 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Mechanical Dyssynchrony

Active Comparator group

Description:

Those with cardiac MRI evidence of mechanical dyssynchrony

Treatment:

Procedure: Temporary pacing study

Radiation: Body Surface Mapping

No Mechanical Dyssynchrony

Active Comparator group

Description:

Those without mechanical dyssynchrony on cardiac MRI

Treatment:

Procedure: Temporary pacing study

Radiation: Body Surface Mapping