Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates
- Conditions
- Heart Failure
- Interventions
- Device: CRT with triple site ventricular stimulationDevice: Conventional cardiac resynchronization
- Registration Number
- NCT00887237
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TRIV CRT with triple site ventricular stimulation Cardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead) BIV Conventional cardiac resynchronization Conventional cardiac resynchronization
- Primary Outcome Measures
Name Time Method Safety of triple site CRT compared to conventional CRT 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (12)
University hospital of Lille
🇫🇷Lille, France
University hospital of Nancy
🇫🇷Nancy, France
University Hospital of Rennes
🇫🇷Rennes, France
University hospital of Bordeaux
🇫🇷Bordeaux, France
University hospital La Timone
🇫🇷Marseille, France
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
Hôpital Saint Louis
🇫🇷La Rochelle, Ile de France, France
University hospital of Montpellier
🇫🇷Montpellier, France
University hospital of Nantes
🇫🇷Nantes, France
Clinique Bizet
🇫🇷Paris, France
Centre Cardiologique du Nord
🇫🇷Saint Denis, France
University hospital of Rouen
🇫🇷Rouen, France