Clinical Trials Directory

Trials / Completed

CompletedNCT01059175

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEAdditional Endocardial or Epicardial LV LeadAddition of a second left ventricular endocardial or epicardial lead
DEVICECRT-P or CRT-DImplantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device

Timeline

Start date
2010-09-01
Primary completion
2014-09-01
Completion
2014-09-01
First posted
2010-01-29
Last updated
2025-07-02
Results posted
2017-04-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01059175. Inclusion in this directory is not an endorsement.