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
| Type | Name | Description |
|---|---|---|
| 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 |
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.