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

NCT ID: NCT03258060

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-08-18

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Mechanical Dyssynchrony

Those with cardiac MRI evidence of mechanical dyssynchrony

Group Type: ACTIVE_COMPARATOR

Temporary pacing study

Intervention Type: PROCEDURE

Body Surface Mapping

Intervention Type: RADIATION

No Mechanical Dyssynchrony

Those without mechanical dyssynchrony on cardiac MRI

Group Type: ACTIVE_COMPARATOR

Temporary pacing study

Intervention Type: PROCEDURE

Body Surface Mapping

Intervention Type: RADIATION

Interventions

Temporary pacing study

Intervention Type: PROCEDURE

Body Surface Mapping

Intervention Type: RADIATION

Other Intervention Names

Electrophysiological study; ECG imaging

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aldo Rinaldi, MBBS MD FHRS

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

Department of Cardiovascular Imaging, King's College London

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

nQRS-CRT

Identifier Type: -

Identifier Source: org_study_id