An interventional study of Additional Endocardial or Epicardial LV Lead and CRT-P or CRT-D in Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 84 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
Device: CRT-P or CRT-D
Addition of a second left ventricular endocardial or epicardial lead
Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
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.
Time frame: 12 months
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.
Time frame: 24 months
Rate of Adverse Events
Time frame: 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
Time frame: 24 months
Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study
Time frame: 24 months
Time to First Heart Failure Related Hospitalization
Time frame: 24 months
Overall Mortality
Time frame: 24 months
Changes in Echocardiographic Indexes of Left Ventricle Remodeling
Changes between baseline and 24months follow up
Time frame: 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.
Time frame: 24 months
| Milestone | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Started | 43 | 41 |
| Completed | 22 | 21 |
| Not completed | 21 | 20 |
| Withdrew: Death | 17 | 17 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| participants | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Improved patients | 11 | 7 |
| Unchanged patients | 10 | 16 |
| Worsened patients | 21 | 17 |
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.
| participants | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Patients improved | 8 | 3 |
| Patients unchanged | 8 | 12 |
| Patients worsened | 26 | 25 |
| participants | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Patients with at least one AE | 38 | 34 |
| Patients with at least one severe AE | 33 | 33 |
Changes between baseline and 24months follow up
| meters | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study | -15.1 ± 88.0 | 7.5 ± 96.3 |
| participants | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study | 19 | 22 |
| days | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Time to First Heart Failure Related Hospitalization | 357.6 ± 27.17 | 402.4 ± 41.16 |
| participants | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Overall Mortality | 17 | 17 |
Changes between baseline and 24months follow up
| milliliter | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Changes in LVEDV | -16.4 ± 78.6 | 7.0 ± 72.1 |
| Changes in LVESV | -14.3 ± 57.6 | -2.0 ± 60.6 |
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.
| units on a scale | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire | -7.33 ± 23.5 | -7.48 ± 17.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CRT With Dual Site LV Pacing | — | 33/42 (78.6%) | 38/42 (90.5%) |
| Standard CRT | — | 33/41 (80.5%) | 34/41 (82.9%) |
| Event | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Severe cardiovascular eventCardiac disorders | 33/42 | 33/41 |
| Event | CRT With Dual Site LV Pacing | Standard CRT |
|---|---|---|
| Cardiac AECardiac disorders | 38/42 | 34/41 |
One patient of the V3 group was not included in the ITT analysis of efficacy results as he did not meet inclusion criteria so 83 pts were analyzed
| Age, Continuous(years) | CRT With Dual Site LV Pacing | Standard CRT | Total |
|---|---|---|---|
| Mean | 70.5 ± 7.7 | 72.2 ± 7.9 | 71.3 ± 7.8 |
| Sex: Female, Male(Participants) | CRT With Dual Site LV Pacing | Standard CRT | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 36 | 36 | 72 |
| Patients with ischemic heart disease(participants) | CRT With Dual Site LV Pacing | Standard CRT | Total |
|---|---|---|---|
| Number | 22 | 24 | 46 |
| Paced QRS duration(milliseconds) | CRT With Dual Site LV Pacing | Standard CRT | Total |
|---|---|---|---|
| Mean | 165 ± 30.5 | 155 ± 42.2 | 160 ± 36.8 |
| Time from first CRT implant(months) | CRT With Dual Site LV Pacing | Standard CRT | Total |
|---|---|---|---|
| Mean | 43.5 ± 28.4 | 37.8 ± 23.7 | 40.6 ± 26.2 |
| LVEF % (left ventricle ejection fraction)(percent) | CRT With Dual Site LV Pacing | Standard CRT | Total |
|---|---|---|---|
| Mean | 26.9 ± 6.0 | 25.9 ± 7.0 | 26.4 ± 6.4 |
| LVEDV (left ventricular end-diastolic volume)(milliliter) | CRT With Dual Site LV Pacing | Standard CRT | Total |
|---|---|---|---|
| Mean | 219 ± 85.8 | 206 ± 63.9 | 213 ± 75.7 |
| LVESV (left ventricular end-systolic volume)(milliliter) | CRT With Dual Site LV Pacing | Standard CRT | Total |
|---|---|---|---|
| Mean | 154 ± 61.8 | 149 ± 58.7 | 151 ± 59.8 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure