Journal of Cardiac Failure
Volume 16, Issue 9 , Pages 709-713, September 2010

Addition of a Second LV Pacing Site in CRT Nonresponders Rationale and Design of the Multicenter Randomized V3 Trial

  • Pierre Bordachar, MD

      Affiliations

    • Hopital Haut Leveque, Pessac, France
    • Corresponding Author InformationReprint requests: Pierre Bordachar, MD, Hospital Haut Leveque, Service Pr. Clementy, Pessac 33604, France. Tel: 33 5 57 65 65 65; Fax: 33 5 57 65 65 09.
    • ,
  • Christine Alonso, MD

      Affiliations

    • Clinique Medico-chirurgicale Bizet, Paris, France
    • ,
  • Frederic Anselme, MD

      Affiliations

    • CHU Charles Nicolle, Rouen, France
    • ,
  • Serge Boveda, MD

      Affiliations

    • Clinique Pasteur, Toulouse, France
    • ,
  • Pascal Defaye, MD

      Affiliations

    • CHU Grenoble, La Tronche, France
    • ,
  • Stephane Garrigue, MD

      Affiliations

    • CliniqueSaint Augustin, Bordeaux, France
    • ,
  • Daniel Gras, MD

      Affiliations

    • Nouvelles Cliniques Nantaises, Nantes, France
    • ,
  • Didier Klug, MD

      Affiliations

    • CHRU Lille, Lille, France
    • ,
  • Olivier Piot, MD

      Affiliations

    • Centre Cardiologique du Nord, Saint Denis, France
    • ,
  • Nicolas Sadoul, MD

      Affiliations

    • CHU de Brabois, Vandoeuvre les Nancy, France
    • ,
  • Christophe Leclercq, MD

      Affiliations

    • CHU Pontchaillou, Rennes, France

Received 24 February 2010; received in revised form 21 April 2010; accepted 29 April 2010. published online 07 June 2010.

Abstract 

Background

Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex. It is limited by a high proportion of nonresponders. Attempts have been made, in small studies, to increase the number of stimulation sites 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 LV lead in nonresponders after at least 6 months of standard biventricular stimulation.

Methods and Results

A total of 84 patients will be enrolled in 11 French medical centers. Patients will be randomly assigned to receive either an additional LV lead (test group) or to keep their current stimulation system unchanged (control group). Enrollment is planned to begin in March 2010 and is expected to end within 1 year. The primary study end point will be the HF clinical composite score evaluated at 1 year follow-up. Secondary end points include degree of echocardiographic reverse remodeling and changes in clinical measurements.

Conclusions

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

Key Words: Heart failure, cardiac resynchronization therapy, biventricular stimulation, multisite stimulation, clinical trial design, non responders

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 See page 712 for disclosure information.

PII: S1071-9164(10)00202-2

doi:10.1016/j.cardfail.2010.04.010

Journal of Cardiac Failure
Volume 16, Issue 9 , Pages 709-713, September 2010

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