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RESynchronisation in Patients With Heart Failure and a Normal QRS Duration

NCT00480051 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-02-28

No results posted yet for this study

Summary

Patients who have heart failure and have electrical evidence of delay in the contraction of the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing. Recent work has suggested that patients with heart failure who do not have electrical evidence of conduction delay (normal QRS) may benefit from biventricular pacing. The reliance on ECGs to determine the presence of dyssynchrony is widespread, although the ECG alone is not 100% sensitive and specific. ECG criteria for de-synchrony in heart failure patients are estimated to pick up only 30% of patients with dyssynchrony, and results in patients missing out on a potentially important treatment advance.

We would like to study patients with heart failure who have normal ventricular activation on their ECGs to see whether we can predict those patients who will respond to biventricular pacing.

Conditions

  • Heart Failure, Congestive

Interventions

DEVICE

Cardiac Resynchronization Pacing

Sponsors & Collaborators

  • Sandwell & West Birmingham Hospitals NHS Trust

    collaborator OTHER

  • Heart of England NHS Trust

    lead OTHER

Principal Investigators

  • Francisco Leyva, MD MB BS · University of Birmingham

  • Paul W Foley, MB ChB MRCP · Heart of England NHS Foundation Trust

  • Kiran Patel, PhD MRCP · Sandwell & West Birmingham Hospitals NHS Trust

  • Berthold Stegemann, PhD · Bakken Research Centre, The Netherlands

  • Russell EA Smith, FRCP MD · University Hospital Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United Kingdom

Study Locations

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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 NCT00480051 on ClinicalTrials.gov