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

NCT ID: NCT04322877

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Body surface mapping and temporary pacing

Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping.

Group Type EXPERIMENTAL

Temporary pacing Study

Intervention Type PROCEDURE

Temporary delivery of CRT

Thoracic CT

Intervention Type RADIATION

As part of non-invasive mapping protocol

Acute hemodynamic study

Intervention Type DIAGNOSTIC_TEST

Measurement of invasive dP/dTmax

Non-invasive body surface mapping

Intervention Type DIAGNOSTIC_TEST

Cardioinsight body surface mapping

Catheter-based mapping and temporary pacing

Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping.

Group Type EXPERIMENTAL

Temporary pacing Study

Intervention Type PROCEDURE

Temporary delivery of CRT

Acute hemodynamic study

Intervention Type DIAGNOSTIC_TEST

Measurement of invasive dP/dTmax

Invasive catheter-based mapping

Intervention Type DIAGNOSTIC_TEST

Invasive electroanatomical mapping

Interventions

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Temporary pacing Study

Temporary delivery of CRT

Intervention Type PROCEDURE

Thoracic CT

As part of non-invasive mapping protocol

Intervention Type RADIATION

Acute hemodynamic study

Measurement of invasive dP/dTmax

Intervention Type DIAGNOSTIC_TEST

Non-invasive body surface mapping

Cardioinsight body surface mapping

Intervention Type DIAGNOSTIC_TEST

Invasive catheter-based mapping

Invasive electroanatomical mapping

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Electrophysiology study

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guys and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Christopher A Rinaldi, MBBS MD FHRS

Role: CONTACT

02071889257

Facility Contacts

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Christopher A Rinaldi

Role: primary

02071889257

Other Identifiers

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125230

Identifier Type: -

Identifier Source: org_study_id

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