A Phase 3 interventional study of CRT with triple site ventricular stimulation and Conventional cardiac resynchronization in Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-08.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Phase 3, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 76 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead)
Device: CRT with triple site ventricular stimulation
Conventional cardiac resynchronization
Device: Conventional cardiac resynchronization
CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)
Conventional cardiac resynchronization
Safety of triple site CRT compared to conventional CRT
Time frame: 6 months
Feasibility of triple site CRT
Time frame: 6 months
Left ventricle remodeling
Time frame: At 3 and 6 months
LV ejection fraction
Time frame: At 3 and 6 months
Cardiac dyssynchrony
Time frame: At 3 and 6 months
Functional status (clinical composite score and NYHA class)
Time frame: At 3 and 6 months
Exercise capacity (6 minutes hall walk test distance)
Time frame: At 3 and 6 months
Quality of life
Time frame: At 3 and 6 months
B-Type Natriuretic Peptide (BNP) level
Time frame: 6 months
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure