Heart FailureV3NCT01059175
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
A study testing Additional Endocardial or Epicardial LV Lead and CRT-P or CRT-D in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Additional Endocardial or Epicardial LV Lead and CRT-P or CRT-D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial
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
- Being tested
- Additional Endocardial or Epicardial LV Lead, CRT-P or CRT-D
- Keywords
- Heart failure, Cardiac resynchronization therapy, Biventricular stimulation, Multisite stimulation, Non responders
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional Endocardial or Epicardial LV LeadDevice
Addition of a second left ventricular endocardial or epicardial lead
CRT-P or CRT-DDevice
Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: CRT-P or CRT-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
- 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.
Measured: 12 months
Secondary outcomes (8)
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.
Measured: 24 months
Rate of Adverse Events
Measured: 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
Measured: 24 months
Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study
Measured: 24 months
Time to First Heart Failure Related Hospitalization
Measured: 24 months
Overall Mortality
Measured: 24 months
Changes in Echocardiographic Indexes of Left Ventricle Remodeling
Changes between baseline and 24months follow up
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic, FRANCE
- Responsible party
- Sponsor
- Investigators
- Bordachar, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059175
- Sponsor's protocol ID
- Medtronic
- Acronym
- V3
- Status last verified
- Apr 2017
- First submitted
- 26 Jan 2010
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20797593Bordachar 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.
PubMed 29288035
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial
- ClinicalTrials.gov ID
- NCT01059175
- Acronym / sponsor ID
- V3 / Medtronic
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cardiac resynchronization therapy, Biventricular stimulation, Multisite stimulation, Non responders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic, FRANCE
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT With Dual Site LV Pacing | Experimental | Device: Additional Endocardial or Epicardial LV Lead, Device: CRT-P or CRT-DCardiac 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 | Device: CRT-P or CRT-DConventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional Endocardial or Epicardial LV LeadAddition of a second left ventricular endocardial or epicardial lead | Device | CRT With Dual Site LV Pacing |
| CRT-P or CRT-DImplantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device | Device | CRT With Dual Site LV Pacing, Standard CRT |
Primary outcome
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
Time frame: 12 months
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.
8 secondary outcomes
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
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
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
Time frame: 24 months
Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20797593Bordachar 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.
- Derived from this study: PubMed 29288035Bordachar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bordachar, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional Endocardial or Epicardial LV Lead and CRT-P or CRT-D in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01059175, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.