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

NCT ID: NCT01059175

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-09-30

Brief Summary

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Additional Endocardial or Epicardial LV Lead

Intervention Type: DEVICE

Addition of a second left ventricular endocardial or epicardial lead

CRT-P or CRT-D

Intervention Type: DEVICE

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

Standard CRT

Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.

Group Type: ACTIVE_COMPARATOR

CRT-P or CRT-D

Intervention Type: DEVICE

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

Interventions

Additional Endocardial or Epicardial LV Lead

Addition of a second left ventricular endocardial or epicardial lead

Intervention Type: DEVICE

CRT-P or CRT-D

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

FRANCE

UNKNOWN

Sponsor Role: collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bordachar, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

University hospital Rennes

Rennes, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 20797593 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29288035 (View on PubMed)

Other Identifiers

Medtronic

Identifier Type: -

Identifier Source: org_study_id