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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01059175
First Posted: January 29, 2010
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medtronic
FRANCE
Information provided by (Responsible Party):
Medtronic Bakken Research Center
  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
Heart Failure Device: Additional Endocardial or Epicardial LV Lead Device: CRT-P or CRT-D

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 ]

    M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved.

    Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened.

    Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.

    Unchanged : if none of the previous definition applies.



Secondary Outcome Measures:
  • Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score [ Time Frame: 24 months ]

    Distribution of "improved", "unchanged" and "worsened" patients as defined per M. Packer's clinical composite score at 24 months post implantation of the second left ventricle lead in comparison to the control group M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 24 months follow up : worsened, unchanged, or improved.

    Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 24-month visit, or if investigator judges global clinical state has worsened.

    Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.

    Unchanged : if none of the previous definition applies.


  • Rate of Adverse Events [ Time Frame: 24 months ]
  • Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study [ Time Frame: 24 months ]
    Changes between baseline and 24months follow up

  • Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study [ Time Frame: 24 months ]
  • Time to First Heart Failure Related Hospitalization [ Time Frame: 24 months ]
  • Overall Mortality [ Time Frame: 24 months ]
  • Changes in Echocardiographic Indexes of Left Ventricle Remodeling [ Time Frame: 24 months ]
    Changes between baseline and 24months follow up

  • Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire [ Time Frame: 24 months ]
    Changes between baseline and 24 months follow up Minesota Living with Heart Failure Questionnaire: 21 questions - addition of scores from 1 (better) to 5 (worse) for each questions.


Enrollment: 84
Study Start Date: September 2010
Study Completion Date: September 2014
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059175


Locations
France
University hospital Rennes
Rennes, France, 35000
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
FRANCE
Investigators
Principal Investigator: 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
First Submitted: January 26, 2010
First Posted: January 29, 2010
Results First Submitted: May 25, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: April 2017

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