Status:
COMPLETED
A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
Lead Sponsor:
University Hospitals, Leicester
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patients are randomised to receive ongoing optimised device and medical therapy or triple ventricular site resynchronisation. The hypothesis states that patients receiving triple-site resynchronizatio...
Eligibility Criteria
Inclusion
- Implanted with a CRT device \> 6 months previously according to current and conventional CRT indications
- Device optimization \> 1 months previously
- Aged 18yrs or older
- Able to attend outpatient follow up
Exclusion
- Recent MI (\<2 months)
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00941850
Start Date
July 1 2009
End Date
November 1 2012
Last Update
December 8 2015
Active Locations (1)
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1
University of Leicester HNS trust
Leicester, England, United Kingdom, LE3 9QP