Mechanisms and Innovations in Cardiac Resynchronisation Therapy

NCT04221763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-03-22

No results posted yet for this study

Summary

The aim of this study is to compare the effectiveness of multiple modalities of cardiac resynchronisation therapy using high precision acute electrical and haemodynamic measurements.These modalities include biventricular pacing and conduction system pacing utilising His bundle and left bundle pacing. Conduction system pacing is a more physiological form of pacing. The study hypothesises that this will produce more effective cardiac resynchronisation.

Conditions

  • Heart Failure
  • Left Ventricular Systolic Dysfunction
  • Left Bundle-Branch Block
  • Right Bundle-Branch Block
  • Non-Specific Intraventricular Conduction Defect

Interventions

DEVICE

His-bundle pacing.

Cardiac resynchronisation therapy can be achieved using biventricular pacing involving placement of three leads into the right atrium, right ventricle and coronary sinus (epicardial left ventricle). Alternatively the third lead may be placed at the bundle of His or left ventricular septum to pace the left bundle directly.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Zachary Whinnett, BM BS B · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2022-12-01
Completion
2022-12-01
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04221763 on ClinicalTrials.gov