Triple Site Ventricular Stimulation for CRT Candidates
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 76
- Locations
- 12
- Primary Endpoint
- Safety of triple site CRT compared to conventional CRT
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Safety of triple site CRT compared to conventional CRT
Time Frame: 6 months
Secondary Outcomes
- 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)