NCT04322877

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

March 24, 2020

Last Update Submit

March 26, 2020

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Improvement in LV dP/dTmax >10 percent during temporary multisite pacing

    Intra-procedure

Secondary Outcomes (1)

  • Electrical dyssynchrony measured from electro-anatomical mapping

    Intra-procedure

Study Arms (2)

Body surface mapping and temporary pacing

EXPERIMENTAL

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

Procedure: Temporary pacing StudyRadiation: Thoracic CTDiagnostic Test: Acute hemodynamic studyDiagnostic 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 StudyDiagnostic Test: Acute hemodynamic studyDiagnostic Test: Invasive catheter-based mapping

Interventions

Temporary pacing StudyPROCEDURE

Temporary delivery of CRT

Also known as: Electrophysiology study
Body surface mapping and temporary pacingCatheter-based mapping and temporary pacing
Thoracic CTRADIATION

As part of non-invasive mapping protocol

Body surface mapping and temporary pacing
Acute hemodynamic studyDIAGNOSTIC_TEST

Measurement of invasive dP/dTmax

Body surface mapping and temporary pacingCatheter-based mapping and temporary pacing
Non-invasive body surface mappingDIAGNOSTIC_TEST

Cardioinsight body surface mapping

Body surface mapping and temporary pacing
Invasive catheter-based mappingDIAGNOSTIC_TEST

Invasive electroanatomical mapping

Catheter-based mapping and temporary pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Christopher A Rinaldi, MBBS MD FHRS

CONTACT

02071889257aldo.rinaldi@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

September 1, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)