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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Additional Endocardial or Epicardial LV Lead; Device: CRT-P or CRT-D

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • University Hospital Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score	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.	24 months
Rate of Adverse Events		24 months
Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study	Changes between baseline and 24months follow up	24 months
Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study		24 months
Time to First Heart Failure Related Hospitalization		24 months
Overall Mortality		24 months
Changes in Echocardiographic Indexes of Left Ventricle Remodeling	Changes between baseline and 24months follow up	24 months
Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire	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.	24 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: Medtronic; FRANCE
• Investigators: Principal Investigator: Bordachar, MD, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Bordachar P, Alonso C, Anselme F, Boveda S, Defaye P, Garrigue S, Gras D, Klug D, Piot O, Sadoul N, Leclercq C. Addition of a second LV pacing site in CRT nonresponders rationale and design of the multicenter randomized V(3) trial. J Card Fail. 2010 Sep;16(9):709-13. doi: 10.1016/j.cardfail.2010.04.010. Epub 2010 Jun 8.
• Bordachar P, Gras D, Clementy N, Defaye P, Mondoly P, Boveda S, Anselme F, Klug D, Piot O, Sadoul N, Babuty D, Leclercq C. Clinical impact of an additional left ventricular lead in cardiac resynchronization therapy nonresponders: The V3 trial. Heart Rhythm. 2018 Jun;15(6):870-876. doi: 10.1016/j.hrthm.2017.12.028. Epub 2017 Dec 26.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 28, 2010
• First Posted (Estimated): January 29, 2010

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Heart failure; Cardiac resynchronization therapy; Biventricular stimulation; Multisite stimulation; Non responders
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: Medtronic