End-stage Heart FailureAMBU-VADNCT04768322
LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients
A study testing HeartMate 3 TM Left Ventricular Assist System and Guideline Directed Medical Therapy in people with End-stage Heart Failure, run by Hospices Civils de Lyon at 8 sites in France.
Trial summary
Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide. Up to 10% of these patients are in advanced stage heart failure, which is defined by a significant morbimortality and considerable medical expenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Heart Failure
- What is being tested?
- HeartMate 3 TM Left Ventricular Assist System and Guideline Directed Medical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 8 sitesFrance
- Study dates
- 24 Feb 2021to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All patients ≥18 years,
- End-stage heart failure, evaluated by the local Heart Team, defined as:
- Left ventricular ejection fraction ≤ 35% within 1 week prior to randomization and
- Cardiac Index < 2.2 L/min/m² by hemodynamic use within 1 month prior to randomization or VO2 max < 14 ml/kg/min (or <50% of predicted VO2max) within 1 month prior to randomization OR low 6-min walking test (< 420 m) within 1 month prior to randomization or ≥ 2 hospitalizations for heart failure in the past year and
- NYHA III-IV (INTERMACS profile 4-6) and and
- Receiving medical management with optimal doses of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible) and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors for at least 45 days if tolerated according to guideline at maximal tolerated dose (if maximal HF drug dosage is not reached the investigators will have to explain reason behind not maximal dosage).
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- Receiving Cardiac Resynchronization Therapy and or Implantable Cardioverter Defibrillators if indicated for at least 45 days and
- No mechanical circulatory support or inotrope therapy since > 30 days,
- Having a health coverage,
- Signed written informed consent,
- Patient without any legal protection measure.
Who cannot join
- Inotrope dependent patients or existence of ongoing mechanical circulatory support (MCS) in the last 30 days,
- Right ventricular dysfunction (heart team consensus) with the expected need of Bi-VAD support,
- Female patients currently pregnant or women of childbearing age who were not using contraception,
- Active infection,
- Irreversible end-organ dysfunction prior to LVAD implantation,
- Contraindication to anti-coagulant or anti-platelet therapies,
Show all 14Show fewer
- History of any organ transplant prior to inclusion,
- Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues likely to impair compliance,
- Frailty according to heart team,
- Platelet count < 100,000 x 103/liter (<100,000/ml)
- Body Surface Area (BSA) < 1.2 m2,
- Any condition other than heart failure that could limit survival to less than 24 months,
- Chronic renal insufficiency (GFR definitely <30 ml/min) or hepatic cirrhosis,
- Participation in any other interventional clinical investigation.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Géraldine SAMSON contact
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHU Besançon
Besançon
MARIE FRANCE SERONDE, Pr
MARIE FRANCE SERONDE, Pr
- Recruiting
Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Bron
MATTEO POZZI, Dr, 4 72 35 71 49 ext. +33, matteo.pozzi@chu-lyon.fr
- Recruiting
CHU Caen
Caen
KATRIEN DR BLANCHART, Dr
KATRIEN DR BLANCHART, Dr
- Recruiting
La Tronche Hospital / CHU Grenoble
La Tronche
AUDE BOIGNARD, aboignard@chu-grenoble.fr
AUDE BOIGNARD, Dr
- Recruiting
Arnaud de Villeneuve Hospital / CHU Montpellier
Montpellier
Valentin DUPASQUIER, valentin.dupasquier@chu-montpellier.fr
PASCAL BAPTISTELLA, Dr
- Recruiting
CHU Rouen
Rouen
FABRICE BAUER
FABRICE BAUER
- Recruiting
CHU Tours
Tours
Thierry BOURGUIGNON, Dr
Thierry BOURGUIGNON
- Recruiting
CHRU, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu
Vandœuvre-lès-Nancy
GUILLAUME BAUDRY, 3 83 15 73 31 ext. 33, g.baudry@chru-nancy.fr
GUILLAUME BAUDRY, Dr
About this study
Official title: Left Ventricular Assist Device (LVAD) Versus Guideline Recommended Medical Therapy in Ambulatory Advanced Heart Failure Patients (GDMT)
Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide. Up to 10% of these patients are in advanced stage heart failure, which is defined by a significant morbimortality and considerable medical expenses. Despite advances in its medical management, advanced (or end stage) heart failure is characterized by refractoriness to conventional therapies including guideline-directed pharmacological and non-surgical device treatments. These patients remain severely symptomatic (NYHA IV) and have objective signs of congestion or low cardiac output.
Left ventricular assist devices (LVADs) have been used in patients with heart failure with reduced ejection fraction for almost 20 years either as an alternative or a bridge to heart transplantation. LVADs improve heart failure symptoms and survival at the cost of increased rates of infection, stroke and bleeding.
Read more
Despite the lack of evidence, LVAD implantation in ambulatory patients is not rare, with INTERMACS profiles ≥4 patients representing 15.7% of the overall population implanted between 2012 and 2016.
The aim of this study is to investigate the efficacy and safety of left ventricular assist devices compared to traditional HF medical treatment alone in a population of ambulatory advanced heart failure patients. Secondary objectives are to better identify subgroups of patients that would benefit the most from the implantation of an LVAD as well as to assess the optimal timing of intervention.
- Conditions
- End-stage Heart Failure
- Being tested
- HeartMate 3 TM Left Ventricular Assist System, Guideline Directed Medical Therapy
- Keywords
- Heart Failure, End-stage, Not inotrope-dependent, Left Ventricular Assist Device, HeartMate 3 system, Heart Surgery, Guideline Directed Medical Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartMate 3 TM Left Ventricular Assist SystemDevice
The HeartMate 3 TM Left Ventricular Assist System will be implanted within 21 days of randomization.
Guideline Directed Medical TherapyOther
Patients randomized in the control group will continue their guideline directed medical therapy which comprises the following stable combination at the maximal tolerated dose of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or Angiotensin receptor Neprilysin inhibitor and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors if tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Early Left Ventricular Assist Device and Guideline Directed Medical Therapy | Experimental | The intervention group will receive an early left ventricular assist device implantation (bridge to transplantation, bridge to candidacy or destination therapy) in addition to guideline directed medical therapy within 21 days of randomization. Receives: Device: HeartMate 3 TM Left Ventricular Assist System; Other: Guideline Directed Medical Therapy |
| Guideline Directed Medical Therapy | Other | Patients randomized in the control group will continue their guideline directed medical therapy which comprises the following stable combination at the maximal tolerated dose of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or Angiotensin receptor Neprilysin inhibitor and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors if tolerated. Receives: Other: Guideline Directed Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality rate
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Measured: Through 24 months when the last subject completes 12 months of follow-up
Number of urgent ECMO implantation
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Measured: Through 24 months when the last subject completes 12 months of follow-up
Number of urgent heart transplantation
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Measured: Through 24 months when the last subject completes 12 months of follow-up
Number of LVAD implantation
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Measured: Through 24 months when the last subject completes 12 months of follow-up
Number of unplanned hospitalization for heart failure
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Measured: Through 24 months when the last subject completes 12 months of follow-up
Quality of life assessed by KCCQ score
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Measured: Through 24 months when the last subject completes 12 months of follow-up
Distance in meters at 6-min walking test
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Measured: Through 24 months when the last subject completes 12 months of follow-up
Secondary outcomes (97)
Number of adverse events (AEs)
Measured: at 1 month
Number of adverse events (AEs)
Measured: at 3 months
Number of adverse events (AEs)
Measured: at 6 months
Number of adverse events (AEs)
Measured: at 12 months
Number of adverse events (AEs)
Measured: at 18 months
Number of adverse events (AEs)
Measured: at 24 months
All-cause mortality rate
Measured: at 1 month
All-cause mortality rate
Measured: at 3 months
All-cause mortality rate
Measured: at 6 months
All-cause mortality rate
Measured: at 12 months
All-cause mortality rate
Measured: at 18 months
All-cause mortality rate
Measured: at 24 months
number of ECMO implantation
Measured: at 1 month
number of ECMO implantation
Measured: at 3 months
number of ECMO implantation
Measured: at 6 months
number of ECMO implantation
Measured: at 12 months
number of ECMO implantation
Measured: at 18 months
number of ECMO implantation
Measured: at 24 months
number of urgent heart transplantation
Measured: at 1 month
number of urgent heart transplantation
Measured: at 3 months
number of urgent heart transplantation
Measured: at 12 months
number of urgent heart transplantation
Measured: at 18 months
number of urgent heart transplantation
Measured: at 24 months
VAD implantation rate
Measured: at 1 month
VAD implantation rate
Measured: at 3 months
VAD implantation rate
Measured: at 6 months
VAD implantation rate
Measured: at 12 months
VAD implantation rate
Measured: at 18 months
VAD implantation rate
Measured: at 24 months
Unplanned hospitalization for heart failure rate
Measured: at 1 month
Unplanned hospitalization for heart failure rate
Measured: at 3 months
Unplanned hospitalization for heart failure rate
Measured: at 6 months
Unplanned hospitalization for heart failure rate
Measured: at 12 months
Unplanned hospitalization for heart failure rate
Measured: at 18 months
Unplanned hospitalization for heart failure rate
Measured: at 24 months
Recurrent hospitalizations rate
Defined as total number of hospitalizations
Measured: at 1 month
Recurrent hospitalizations rate
Defined as total number of hospitalizations
Measured: at 3 months
Recurrent hospitalizations rate
Defined as total number of hospitalizations
Measured: at 6 months
Recurrent hospitalizations rate
Defined as total number of hospitalizations
Measured: at 12 months
Recurrent hospitalizations rate
Defined as total number of hospitalizations
Measured: at 18 months
Recurrent hospitalizations rate
Defined as total number of hospitalizations
Measured: at 24 months
Number of patients with a persistence of the eligibility to LVAD implantation
In the GDMT group only
Measured: at 12 and 24 months
Number of patients with a persistence of the eligibility to LVAD implantation
In the GDMT group only
Measured: at 12 months
Number of days alive out of hospital
Measured: at 24 months
New York Heart Association (NYHA) status
Measured: at inclusion
New York Heart Association (NYHA) status
Measured: at 1 month
New York Heart Association (NYHA) status
Measured: at 3 months
New York Heart Association (NYHA) status
Measured: at 6 months
New York Heart Association (NYHA) status
Measured: at 12 months
New York Heart Association (NYHA) status
Measured: at 18 months
New York Heart Association (NYHA) status
Measured: at 24 months
Distance in meters at 6-min walking test
Measured: at inclusion
Distance in meters at 6-min walking test
Measured: at 3 months
Distance in meters at 6-min walking test
Measured: at 6 months
Distance in meters at 6-min walking test
Measured: at 12 months
Distance in meters at 6-min walking test
Measured: at 18 months
Distance in meters at 6-min walking test
Measured: at 24 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Measured: at inclusion
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Measured: at 3 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Measured: at 6 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Measured: at 12 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Measured: at 18 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Measured: at 24 months
Quality of life assessed by KCCQ score
Measured: at inclusion
Quality of life assessed by KCCQ score
Measured: at 3 months
Quality of life assessed by KCCQ score
Measured: at 6 months
Quality of life assessed by KCCQ score
Measured: at 12 months
Quality of life assessed by KCCQ score
Measured: at 18 months
Quality of life assessed by KCCQ score
Measured: at 24 months
Right ventricular function assessed by echocardiographic parameters
Measured: at inclusion
Right ventricular function assessed by echocardiographic parameters
Measured: at 3 months
Right ventricular function assessed by echocardiographic parameters
Measured: at 6 months
Right ventricular function assessed by echocardiographic parameters
Measured: at 12 months
Right ventricular function assessed by echocardiographic parameters
Measured: at 18 months
Right ventricular function assessed by echocardiographic parameters
Measured: at 24 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Measured: at inclusion
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Measured: at 3 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Measured: at 6 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Measured: at 12 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Measured: at 18 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Measured: at 24 months
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Measured: at inclusion
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Measured: at 1 month
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Measured: at 6 months
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Measured: at 12 months
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Measured: at 24 months
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Measured: at inclusion
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Measured: at 1 month
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Measured: at 6 months
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Measured: at 12 months
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Measured: at 24 months
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Measured: at inclusion
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Measured: at 1 month
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Measured: at 3 months
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Measured: at 12 months
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Measured: at 18 months
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start24 Feb 2021
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Heart FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume BAUDRY, Dr, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768322
- Sponsor's protocol ID
- 69HCL20_0072
- Other IDs
- ID-RCB
- Acronym
- AMBU-VAD
- Status last verified
- May 2026
- First submitted
- 17 Feb 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Assist Device (LVAD) Versus Guideline Recommended Medical Therapy in Ambulatory Advanced Heart Failure Patients (GDMT)
- ClinicalTrials.gov ID
- NCT04768322
- Acronym / sponsor ID
- AMBU-VAD / 69HCL20_0072
- Conditions
- End-stage Heart Failure
- Keywords
- Heart Failure, End-stage, Not inotrope-dependent, Left Ventricular Assist Device, HeartMate 3 system, Heart Surgery, Guideline Directed Medical Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide. Up to 10% of these patients are in advanced stage heart failure, which is defined by a significant morbimortality and considerable medical expenses. Despite advances in its medical management, advanced (or end stage) heart failure is characterized by refractoriness to conventional therapies including guideline-directed pharmacological and non-surgical device treatments. These patients remain severely symptomatic (NYHA IV) and have objective signs of congestion or low cardiac output.
Left ventricular assist devices (LVADs) have been used in patients with heart failure with reduced ejection fraction for almost 20 years either as an alternative or a bridge to heart transplantation. LVADs improve heart failure symptoms and survival at the cost of increased rates of infection, stroke and bleeding.
Despite the lack of evidence, LVAD implantation in ambulatory patients is not rare, with INTERMACS profiles ≥4 patients representing 15.7% of the overall population implanted between 2012 and 2016.
The aim of this study is to investigate the efficacy and safety of left ventricular assist devices compared to traditional HF medical treatment alone in a population of ambulatory advanced heart failure patients. Secondary objectives are to better identify subgroups of patients that would benefit the most from the implantation of an LVAD as well as to assess the optimal timing of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Left Ventricular Assist Device and Guideline Directed Medical Therapy | Experimental | Device: HeartMate 3 TM Left Ventricular Assist System, Other: Guideline Directed Medical TherapyThe intervention group will receive an early left ventricular assist device implantation (bridge to transplantation, bridge to candidacy or destination therapy) in addition to guideline directed medical therapy within 21 days of randomization. |
| Guideline Directed Medical Therapy | Other | Other: Guideline Directed Medical TherapyPatients randomized in the control group will continue their guideline directed medical therapy which comprises the following stable combination at the maximal tolerated dose of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or Angiotensin receptor Neprilysin inhibitor and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors if tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All patients ≥18 years,
- End-stage heart failure, evaluated by the local Heart Team, defined as:
- Having a health coverage,
- Signed written informed consent,
- Patient without any legal protection measure.
Key exclusion criteria (14 listed)
- Inotrope dependent patients or existence of ongoing mechanical circulatory support (MCS) in the last 30 days,
- Right ventricular dysfunction (heart team consensus) with the expected need of Bi-VAD support,
- Female patients currently pregnant or women of childbearing age who were not using contraception,
- Active infection,
- Irreversible end-organ dysfunction prior to LVAD implantation,
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 |
|---|---|---|
| HeartMate 3 TM Left Ventricular Assist SystemThe HeartMate 3 TM Left Ventricular Assist System will be implanted within 21 days of randomization. | Device | Early Left Ventricular Assist Device and Guideline Directed Medical Therapy |
| Guideline Directed Medical TherapyPatients randomized in the control group will continue their guideline directed medical therapy which comprises the following stable combination at the maximal tolerated dose of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or Angiotensin receptor Neprilysin inhibitor and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors if tolerated. | Other | Early Left Ventricular Assist Device and Guideline Directed Medical Therapy, Guideline Directed Medical Therapy |
Primary outcome
All-cause mortality rate
Time frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Number of urgent ECMO implantation
Time frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Number of urgent heart transplantation
Time frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Number of LVAD implantation
Time frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Number of unplanned hospitalization for heart failure
Time frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Quality of life assessed by KCCQ score
Time frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Distance in meters at 6-min walking test
Time frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
97 secondary outcomes
Number of adverse events (AEs)
Time frame: at 1 month
Number of adverse events (AEs)
Time frame: at 3 months
Number of adverse events (AEs)
Time frame: at 6 months
Number of adverse events (AEs)
Time frame: at 12 months
Number of adverse events (AEs)
Time frame: at 18 months
Number of adverse events (AEs)
Time frame: at 24 months
All-cause mortality rate
Time frame: at 1 month
All-cause mortality rate
Time frame: at 3 months
All-cause mortality rate
Time frame: at 6 months
All-cause mortality rate
Time frame: at 12 months
All-cause mortality rate
Time frame: at 18 months
All-cause mortality rate
Time frame: at 24 months
number of ECMO implantation
Time frame: at 1 month
number of ECMO implantation
Time frame: at 3 months
number of ECMO implantation
Time frame: at 6 months
number of ECMO implantation
Time frame: at 12 months
number of ECMO implantation
Time frame: at 18 months
number of ECMO implantation
Time frame: at 24 months
number of urgent heart transplantation
Time frame: at 1 month
number of urgent heart transplantation
Time frame: at 3 months
number of urgent heart transplantation
Time frame: at 12 months
number of urgent heart transplantation
Time frame: at 18 months
number of urgent heart transplantation
Time frame: at 24 months
VAD implantation rate
Time frame: at 1 month
VAD implantation rate
Time frame: at 3 months
VAD implantation rate
Time frame: at 6 months
VAD implantation rate
Time frame: at 12 months
VAD implantation rate
Time frame: at 18 months
VAD implantation rate
Time frame: at 24 months
Unplanned hospitalization for heart failure rate
Time frame: at 1 month
Unplanned hospitalization for heart failure rate
Time frame: at 3 months
Unplanned hospitalization for heart failure rate
Time frame: at 6 months
Unplanned hospitalization for heart failure rate
Time frame: at 12 months
Unplanned hospitalization for heart failure rate
Time frame: at 18 months
Unplanned hospitalization for heart failure rate
Time frame: at 24 months
Recurrent hospitalizations rate
Time frame: at 1 month
Recurrent hospitalizations rate
Time frame: at 3 months
Recurrent hospitalizations rate
Time frame: at 6 months
Recurrent hospitalizations rate
Time frame: at 12 months
Recurrent hospitalizations rate
Time frame: at 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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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.
Géraldine SAMSON contact
Guillaume BAUDRY, Dr principal investigator
CHRU Nancy
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartMate 3 TM Left Ventricular Assist System and Guideline Directed Medical Therapy in people with End-stage Heart Failure, run by Hospices Civils de Lyon at 8 sites 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 11 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume BAUDRY, Dr (383157331 ext. +33, g.baudry@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality rate (time frame: Through 24 months when the last subject completes 12 months of follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.