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

NCT01059175 | Completed Results DMC

• 1 other identifier: Medtronic
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Heart failure; Cardiac resynchronization therapy; Biventricular stimulation; Multisite stimulation; Non responders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score

  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

  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

Study Arms (2)

CRT With Dual Site LV Pacing

EXPERIMENTAL

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; Device: CRT-P or CRT-D

Standard CRT

ACTIVE COMPARATOR

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

Device: CRT-P or CRT-D

Interventions

Additional Endocardial or Epicardial LV Lead DEVICE

Addition of a second left ventricular endocardial or epicardial lead

CRT With Dual Site LV Pacing

CRT-P or CRT-D DEVICE

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

CRT With Dual Site LV Pacing; Standard CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator
• FRANCE: collaborator

Study Sites (1)

University hospital Rennes

Rennes, 35000, France

Location

Related Publications (2)

• 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.

  PMID: 20797593 BACKGROUND

• 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.

  PMID: 29288035 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Latifa Foudali
• Organization: Medtronic

latifa.foudali@medtronic.com

+33 631992144

Study Officials

• Bordachar, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 29, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 2, 2025
• Results First Posted: April 21, 2017

Record last verified: 2017-04

Locations

FR (1)