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

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: CRT with triple site ventricular stimulation Device: Conventional cardiac resynchronization Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Triple Site Ventricular Stimulation for CRT Candidates
Study Start Date : May 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: TRIV
Cardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead)
Device: CRT with triple site ventricular stimulation
CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)
Active Comparator: BIV
Conventional cardiac resynchronization
Device: Conventional cardiac resynchronization
Conventional cardiac resynchronization

Primary Outcome Measures :
  1. Safety of triple site CRT compared to conventional CRT [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Feasibility of triple site CRT [ Time Frame: 6 months ]
  2. Left ventricle remodeling [ Time Frame: At 3 and 6 months ]
  3. LV ejection fraction [ Time Frame: At 3 and 6 months ]
  4. Cardiac dyssynchrony [ Time Frame: At 3 and 6 months ]
  5. Functional status (clinical composite score and NYHA class) [ Time Frame: At 3 and 6 months ]
  6. Exercise capacity (6 minutes hall walk test distance) [ Time Frame: At 3 and 6 months ]
  7. Quality of life [ Time Frame: At 3 and 6 months ]
  8. B-Type Natriuretic Peptide (BNP) level [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00887237

Hôpital Saint Louis
La Rochelle, Ile de France, France, 17000
University hospital of Bordeaux
Bordeaux, France, 33000
University hospital of Lille
Lille, France, 59000
University hospital La Timone
Marseille, France, 13000
University hospital of Montpellier
Montpellier, France, 34000
University hospital of Nancy
Nancy, France, 54000
Nouvelles Cliniques Nantaises
Nantes, France, 44000
University hospital of Nantes
Nantes, France, 44000
Clinique Bizet
Paris, France, 75016
University Hospital of Rennes
Rennes, France, 35000
University hospital of Rouen
Rouen, France, 76031
Centre Cardiologique du Nord
Saint Denis, France, 93200
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Principal Investigator: Frederic Anselme, Pr University Hospital, Rouen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT00887237     History of Changes
Other Study ID Numbers: TRIV
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Heart failure
Cardiac resynchronization
Triple site ventricular pacing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases