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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322877
• Other study ID #: 125230
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2020
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Christopher A Rinaldi, MBBS MD FHRS
• Phone: 02071889257
• Email: aldo.rinaldi[@]kcl.ac.uk
• 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). The investigators aim to assess acute response to CRT and compare different methods of delivering CRT using hemodynamic data from invasive dP/dTmax and electroanatomical data from either invasive mapping or non-invasive body surface mapping.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• 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.

• 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 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.

• 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
Temporary delivery of CRT

Radiation:
• Thoracic CT
As part of non-invasive mapping protocol

Diagnostic Test:
• Acute hemodynamic study
Measurement of invasive dP/dTmax
• Non-invasive body surface mapping
Cardioinsight body surface mapping
• Invasive catheter-based mapping
Invasive electroanatomical mapping

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas' NHS Foundation Trust	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	Improvement in LV dP/dTmax >10 percent during temporary multisite pacing		Intra-procedure
Secondary	Electrical dyssynchrony measured from electro-anatomical mapping		Intra-procedure