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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00887237
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : July 8, 2013
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

April 22, 2009
April 23, 2009
July 8, 2013
May 2009
July 2012   (Final data collection date for primary outcome measure)
Safety of triple site CRT compared to conventional CRT [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00887237 on Archive Site
  • 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 ]
Same as current
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Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates
Triple Site Ventricular Stimulation for CRT Candidates

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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Heart Failure
  • 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
  • Experimental: TRIV
    Cardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead)
    Intervention: Device: CRT with triple site ventricular stimulation
  • Active Comparator: BIV
    Conventional cardiac resynchronization
    Intervention: Device: Conventional cardiac resynchronization
Anselme F, Bordachar P, Pasquié JL, Klug D, Leclercq C, Milhem A, Alonso C, Deharo JC, Gras D, Probst V, Piot O, Savouré A. Safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization. Heart Rhythm. 2016 Jan;13(1):183-9. doi: 10.1016/j.hrthm.2015.08.036. Epub 2015 Sep 26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Medtronic Cardiac Rhythm and Heart Failure
Medtronic Cardiac Rhythm and Heart Failure
Not Provided
Principal Investigator: Frederic Anselme, Pr University Hospital, Rouen
Medtronic Cardiac Rhythm and Heart Failure
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP