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

Heart Failure Clinical Trial

Official title:

Cardiac Resynchronisation Therapy In Patients With Narrow QRS Morphology And Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03258060
• Other study ID #: nQRS-CRT
• Status: Terminated
• Phase: N/A
• First received: March 17, 2014
• Last updated: August 18, 2017
• Start date: April 2014
• Est. completion date: August 18, 2017

Study information

• Verified date: August 2017
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 18, 2017
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Temporary pacing study

Radiation:
• Body Surface Mapping

Locations

Country	Name	City	State
United Kingdom	Department of Cardiovascular Imaging, King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV dP/dT during pacing	To assess LV dP/dT during different pacing modalities by intraventricular pressure wire. A dP/dT change of >10% from baseline is a positive result.	during temporary pacing study, approximately 2 hours
Secondary	Correlation of electrical and mechanical dyssynchrony	To correlate the amount of mechanical dyssynchrony seen prior to pacing with electrical dyssynchrony measures from non-contact mapping and body surface mapping	Data is collected prior to temporary pacing study, the post processing needed in order to correlate this data may take up to 2 months