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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00887237
First received: April 22, 2009
Last updated: July 3, 2013
Last verified: July 2013

April 22, 2009
July 3, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00887237 on ClinicalTrials.gov Archive Site
  • Feasibility of triple site CRT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Left ventricle remodeling [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • LV ejection fraction [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • Cardiac dyssynchrony [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • Functional status (clinical composite score and NYHA class) [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • Exercise capacity (6 minutes hall walk test distance) [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • B-Type Natriuretic Peptide (BNP) level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00887237
TRIV
Yes
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Principal Investigator: Frederic Anselme, Pr University Hospital, Rouen
Medtronic Cardiac Rhythm Disease Management
July 2013

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