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
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: Additional Endocardial or Epicardial LV Lead
Device: CRT-P or CRT-D
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 84
Study Start Date: September 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Active Comparator: Standard CRT
Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
Device: CRT-P or CRT-D
Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059175

Locations
France
University hospital Rennes
Rennes, France, 35000
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
FRANCE
Investigators
Principal Investigator: Pierre Bordachar, MD University Hospital of Bordeaux
  More Information

Publications:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01059175     History of Changes
Other Study ID Numbers: Medtronic
Study First Received: January 26, 2010
Last Updated: December 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Medtronic Bakken Research Center:
Heart failure
Cardiac resynchronization therapy
Biventricular stimulation
Multisite stimulation
Non responders

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014