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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014