Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates

Study Overview
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Brief Summary
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Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT. One might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of the cardiac dyssynchrony. The present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective- and to assess its clinical benefit.

Official Title
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Triple Site Ventricular Stimulation for CRT Candidates

Conditions
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Heart Failure

Intervention / Treatment
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* Device: CRT with triple site ventricular stimulation
* Device: Conventional cardiac resynchronization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent > 18 years old Cardiac resynchronization indication : New York Heart Association (NYHA) Class III/IV & QRS width > 120 ms milliseconds (ms) OR NYHA class II & QRS width > 150 ms Sinus rhythm First implant procedure Exclusion Criteria: Permanent ventricular tachycardia Permanent pacing indication for 3rd degree atrioventricular (AV) block Diagnosed or suspected acute myocarditis Less than 1 year life expectancy related to a non-cardiovascular disease Impossibility to perform follow-up in the investigative center Pregnant woman Patient which may not cooperate to study procedures as evaluated by investigator Legally protected adult patient or patient unable to give an informed consent Patient enrolled in an other clinical trial Patient which does not benefit from a social protection system Renal insufficiency Patient registered on a heart transplant waiting list Disease and/or health condition which may interfere with study results

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRIV<br>Cardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead) | Device: CRT with triple site ventricular stimulation<br>* CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)<br>|
| Active Comparator: BIV<br>Conventional cardiac resynchronization | Device: Conventional cardiac resynchronization<br>* Conventional cardiac resynchronization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of triple site CRT compared to conventional CRT |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of triple site CRT |  | 6 months | 
| Left ventricle remodeling |  | At 3 and 6 months | 
| LV ejection fraction |  | At 3 and 6 months | 
| Cardiac dyssynchrony |  | At 3 and 6 months | 
| Functional status (clinical composite score and NYHA class) |  | At 3 and 6 months | 
| Exercise capacity (6 minutes hall walk test distance) |  | At 3 and 6 months | 
| Quality of life |  | At 3 and 6 months | 
| B-Type Natriuretic Peptide (BNP) level |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Cardiac resynchronization, Triple site ventricular pacing