A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Upgrade to triple ventricular site CRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triple site CRT<br>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 | Procedure: Upgrade to triple ventricular site CRT<br>* 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).<br>|
| No Intervention: Optimised medical and device therapy<br>These patients will receive optimised medical and device therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac resynchronizton therapy, CRT, Heart failure, Dyssynchrony, Echocardiography, Pacemakers, Nonresponders