LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients
ConditionEnd-stage Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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.
Eligibility criteria
Qualifiers
All patients ≥18 years,
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
Disqualifiers
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,
Trial design
Treatments tested in this trial
- HeartMate 3 TM Left Ventricular Assist System
- Guideline Directed Medical Therapy
Treatment groups
92 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov