A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
NCT ID: NCT00941850
Last Updated: 2015-12-08
Study Results
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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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2009-07-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Triple site CRT
These patients will continue to receive CRT via existing device but will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced
Upgrade to triple ventricular site CRT
Patients in this arm will continue to receive CRT via the original unit, but some will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced).
Optimised medical and device therapy
These patients will receive optimised medical and device therapy.
No interventions assigned to this group
Interventions
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Upgrade to triple ventricular site CRT
Patients in this arm will continue to receive CRT via the original unit, but some will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced).
Eligibility Criteria
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Inclusion Criteria
* Device optimization \> 1 months previously
* Aged 18yrs or older
* Able to attend outpatient follow up
Exclusion Criteria
* Women who are pregnant or planning pregnancy
* Severe co morbid illness (where patients are not expected to survive duration of follow up period or where repeated outpatient visits may not be in best interest of patients)
* Upgrade procedure is contraindicated for safety reasons.
* Class IV inotropic agents
* Patient unwilling to comply with required follow-up protocol including randomization scheme
18 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
Responsible Party
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Principal Investigators
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GAndre Ng, MB ChB, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Leicester
Locations
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University of Leicester HNS trust
Leicester, England, United Kingdom
Countries
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Other Identifiers
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UHL10707
Identifier Type: -
Identifier Source: org_study_id