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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| FRANCE | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard CRT | Active Comparator | Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional Endocardial or Epicardial LV Lead | Device | Addition of a second left ventricular endocardial or epicardial lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bordachar, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Rennes | Rennes | 35000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20797593 | Background | 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. | |
| 29288035 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device |
| FG001 | Standard CRT | Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe cardiovascular event | Cardiac disorders | Systematic Assessment | Definition as per ISO 14155 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac AE | Cardiac disorders | Systematic Assessment | Definition as per ISO 14155 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Latifa Foudali | Medtronic | +33 631992144 | latifa.foudali@medtronic.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| CRT-P or CRT-D | Device | Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device |
|
| 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 | Changes between baseline and 24months follow up | 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 |
| Overall Mortality | 24 months |
| Changes in Echocardiographic Indexes of Left Ventricle Remodeling | Changes between baseline and 24months follow up | 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. | 24 months |
| 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. |
| Lost to Follow-up |
|
| BG001 | Standard CRT | Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Patients with ischemic heart disease | Number | participants |
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| Paced QRS duration | Mean | Standard Deviation | milliseconds |
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| Time from first CRT implant | Mean | Standard Deviation | months |
|
| LVEF % (left ventricle ejection fraction) | Mean | Standard Deviation | percent |
|
| LVEDV (left ventricular end-diastolic volume) | Mean | Standard Deviation | milliliter |
|
| LVESV (left ventricular end-systolic volume) | Mean | Standard Deviation | milliliter |
|
| OG001 | Standard CRT | Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device |
|
|
| Secondary | 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. | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Rate of Adverse Events | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study | Changes between baseline and 24months follow up | Posted | Mean | Standard Deviation | meters | 24 months |
|
|
|
| Secondary | Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Time to First Heart Failure Related Hospitalization | Posted | Mean | Standard Error | days | 24 months |
|
|
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| Secondary | Overall Mortality | Posted | Number | participants | 24 months |
|
|
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| Secondary | Changes in Echocardiographic Indexes of Left Ventricle Remodeling | Changes between baseline and 24months follow up | Number of patients with data available for analysis of this objective | Posted | Mean | Standard Deviation | milliliter | 24 months |
|
|
|
| Secondary | 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. | Number of patients with data available for analysis of this objective | Posted | Mean | Standard Deviation | units on a scale | 24 months |
|
|
|
| 33 |
| 42 |
| 38 |
| 42 |
| EG001 | Standard CRT | Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device | 33 | 41 | 34 | 41 |
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| Patients worsened |
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| Changes in LVESV |
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