Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial (V3)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medtronic
FRANCE
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01059175
First received: January 26, 2010
Last updated: December 18, 2013
Last verified: December 2013

January 26, 2010
December 18, 2013
September 2010
September 2014   (final data collection date for primary outcome measure)
Distribution of "improved", "unchanged" and "worsened" patients as defined per M. Packer's clinical composite score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01059175 on ClinicalTrials.gov Archive Site
  • Distribution of "improved", "unchanged" and "worsened" patients as defined per M. Packer's clinical composite score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Rate of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Changes in functional capacity, exercise tolerance and quality of life observed between the enrollment and the end of the study [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of hospitalizations related to heart failure between randomization and the end of the study [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to first heart failure related hospitalization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall mortality [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Echocardiographic indexes of LV remodeling [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial

Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex. It is mainly limited by a high proportion of non-responders. Attempts have been made, in small studies, to increase the number of stimulation sites in order to optimize the resynchronization therapy. V3 is a planned multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred by the addition of a second endocardial or epicardial LV lead in non-responders after at least 6 months of standard biventricular stimulation.

The V3 trial will examine the clinical benefit conferred by the addition of a second LV lead in non-responders compared to standard CRT.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Device: Additional Endocardial or Epicardial LV Lead
    Addition of a second left ventricular endocardial or epicardial lead
  • Device: CRT-P or CRT-D
    Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
  • Experimental: CRT With Dual Site LV Pacing
    Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
    Interventions:
    • Device: Additional Endocardial or Epicardial LV Lead
    • Device: CRT-P or CRT-D
  • Active Comparator: Standard CRT
    Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
    Intervention: Device: CRT-P or CRT-D
Bordachar P, Alonso C, Anselme F, Boveda S, Defaye P, Garrigue S, Gras D, Klug D, Piot O, Sadoul N, Leclercq C. Addition of a second LV pacing site in CRT nonresponders rationale and design of the multicenter randomized V(3) trial. J Card Fail. 2010 Sep;16(9):709-13. Epub 2010 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
84
April 2015
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than 18 years
  • Recipient of a CRT-P or CRT-D system for greater than 6 for standard indications, including LV ejection fraction greater than 35 percent and New York Heart Association (NYHA) functional class III or IV
  • Optimized biventricular stimulation and medical therapy since implantation of the system
  • Presence of sinus rhythm, or atrial fibrillation with spontaneous or induced complete atrio-ventricular block
  • Greater than 93 percent LV stimulation since the last device interrogation, with a LV capture threshold less than 5.0 Volts/0.5 milliseconds
  • Unchanged or worsened clinical status by CRT, according to the HF composite endpoint described by M. Packer, in absence of a reversible cause
  • Signature of a written, informed consent to participate in the trial

Exclusion Criteria:

  • LV lead location in the great cardiac vein
  • Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
  • Chronic renal dialysis
  • Concomitant disorder which might interfere with the results of the V3 trial
  • Blood systolic pressure greater than 180 millimeters of mercury (mmHg) or diastolic pressure greater than 95 mmHg despite optimal medical management
  • History of stroke, myocardial infarction or unstable angina pectoris within the last 3 months
  • Presence of correctible valvular disease
  • Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, to comply with the trial's procedures, or to sign the informed consent
  • Subject is pregnant
  • Subject participates in another research project
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01059175
Medtronic
Yes
Medtronic Bakken Research Center
Medtronic Bakken Research Center
  • Medtronic
  • FRANCE
Principal Investigator: Pierre Bordachar, MD University Hospital of Bordeaux
Medtronic Bakken Research Center
December 2013

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