NCT00887237

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

Triple Site Ventricular Stimulation for CRT Candidates

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	CRT with triple site ventricular stimulation	CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)
DEVICE	Conventional cardiac resynchronization	Conventional cardiac resynchronization

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-04-23
• Last updated: 2013-07-08

Locations

12 sites across 1 country: France