Actively Recruiting
LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients
Led by Hospices Civils de Lyon · Updated on 2026-05-08
92
Participants Needed
8
Research Sites
414 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with end-stage heart failure confirmed by a local Heart Team
- Left ventricular ejection fraction of 35% or less within 1 week before randomization
- Cardiac Index below 2.2 L/min/m2 within 1 month prior to randomization or VO2 max less than 14 ml/kg/min or under 50% of predicted VO2 max within 1 month prior to randomization, or a 6-minute walking test distance under 420 meters within 1 month prior to randomization, or at least 2 hospitalizations for heart failure in the past year
- New York Heart Association (NYHA) class III or IV symptoms (INTERMACS profile 4-6)
- Receiving optimal doses of beta-blockers, ACE inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), mineralocorticoid receptor antagonists, and SGLT2 inhibitors for at least 45 days if tolerated
- Receiving cardiac resynchronization therapy and/or implantable cardioverter defibrillators if indicated for at least 45 days
- No mechanical circulatory support or inotrope therapy in the past 30 days
- Have health coverage
- Signed written informed consent
- Not under any legal protection measure
You will not qualify if you...
- Inotrope dependent or receiving mechanical circulatory support within the last 30 days
- Right ventricular dysfunction with expected need for Bi-VAD support
- Currently pregnant or female of childbearing age not using contraception
- Active infection
- Irreversible end-organ dysfunction before LVAD implantation
- Contraindication to anticoagulant or antiplatelet therapies
- History of any organ transplant prior to inclusion
- Psychiatric disease, irreversible cognitive dysfunction, or psychosocial issues likely to impair compliance
- Frailty as determined by the heart team
- Platelet count less than 100,000 per microliter
- Body surface area less than 1.2 m2
- Any non-heart failure condition expected to limit survival to less than 24 months
- Chronic renal insufficiency with GFR less than 30 ml/min or hepatic cirrhosis
- Participation in any other interventional clinical trial
AI-Screening
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Trial Site Locations
Total: 8 locations
1
CHU Besançon
Besançon, France
Actively Recruiting
2
Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Bron, France
Actively Recruiting
3
CHU Caen
Caen, France
Actively Recruiting
4
La Tronche Hospital / CHU Grenoble
La Tronche, France
Actively Recruiting
5
Arnaud de Villeneuve Hospital / CHU Montpellier
Montpellier, France
Actively Recruiting
6
CHU Rouen
Rouen, France
Actively Recruiting
7
CHU Tours
Tours, France
Actively Recruiting
8
CHRU, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu
Vandœuvre-lès-Nancy, France
Actively Recruiting
Research Team
G
Guillaume BAUDRY, Dr
CONTACT
G
Géraldine SAMSON
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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