Cardiac Resynchronisation Therapy In Patients With Heart... | NCT04322877

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

NCT04322877

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Status

Unknown status

Last Update Posted

Mar 30, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Temporary pacing Study
Thoracic CT
Acute hemodynamic study
Non-invasive body surface mapping
Invasive catheter-based mapping

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Sep 30, 2021Estimated

Completion Date

Sep 30, 2021Estimated

First Submitted Date

Mar 24, 2020

First Submission Date that Met QC Criteria

Mar 24, 2020

First Posted Date

Mar 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2020

Last Update Posted Date

Mar 30, 2020Actual

Name	Class
King's College London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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). 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Body surface mapping and temporary pacing	Experimental	Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.	Procedure: Temporary pacing Study Radiation: Thoracic CT Diagnostic Test: Acute hemodynamic study Diagnostic Test: Non-invasive body surface mapping
Catheter-based mapping and temporary pacing	Experimental	Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping.	Procedure: Temporary pacing Study Diagnostic Test: Acute hemodynamic study Diagnostic Test: Invasive catheter-based mapping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Temporary pacing Study	Procedure	Temporary delivery of CRT	Body surface mapping and temporary pacing Catheter-based mapping and temporary pacing

Measure	Description	Time Frame
Improvement in LV dP/dTmax >10 percent during temporary multisite pacing		Intra-procedure

Measure	Description	Time Frame
Electrical dyssynchrony measured from electro-anatomical mapping		Intra-procedure

Eligibility Module

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.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases