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Completed

NCT Number: NCT01059175

Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Rennes

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additional Endocardial or Epicardial LV Lead

Device

Addition of a second left ventricular endocardial or epicardial lead

CRT-P or CRT-D

Device

Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Rate of Adverse Events

    Time frame: 24 months

  3. 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

  4. Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study

    Time frame: 24 months

  5. Time to First Heart Failure Related Hospitalization

    Time frame: 24 months

  6. Overall Mortality

    Time frame: 24 months

  7. Changes in Echocardiographic Indexes of Left Ventricle Remodeling

    Time frame: 24 months

    Changes between baseline and 24months follow up

  8. 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • FRANCE
  • Medtronic

Registry information

Official study title

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

Acronym: V3

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2010
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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