TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy

University Hospitals, Leicester1 site in 1 country20 target enrollmentJuly 2009

ConditionsHeart Failure

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Heart Failure
Sponsor: University Hospitals, Leicester
Enrollment: 20
Locations: 1
Primary Endpoint: Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 resynchronization will exhibit a better response.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospitals, Leicester

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months

Time Frame: 6 months

Secondary Outcomes

NYHA class(3 and 6 months)
ECHO parameters (LVEDV/ESV, LVEF, MR severity, dyssynchrony indices: time to peak velocity/strain/deformation/time to minimal volume)(3 and 6 months)
MVO2 max(6 months)