NCT02592499

Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure

Swedish Evaluation of Left Ventricular Assist Device

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, randomized, non-blinded, national, multi-center study. The study will consist of the assignment of eligible patients to treatment with either a HeartMate III (HM III) left ventricular assist device system or to pharmacological treatment (optimal medical management, OMM) according to current guidelines. Eighty (80) patients will be enrolled in this study and randomized in a 1:1 fashion between the HM III and OMM, based on a modified power calculation.

Detailed description

The primary objective is to compare survival between left Ventricular Assist Device (LVAD) destination therapy and optimal medical management in a Swedish end stage heart failure population ineligible for cardiac transplantation. The secondary objective is to compare treatment groups with respect to organ function, functional capacity, quality of life and adverse events. All patients enrolled in the study will be followed through 2 years. Patients who continue to be on going with the HM III or on OMM past 2 years will continue be followed for their outcomes and adverse events for up to 5 years. Patient recruitment was expected to occur over 24 months, but due to difficulties in recruiting patients will be longer (approximately 48 months) The study will be conducted in Sweden at all 7 University Hospitals and implantations will be performed in 5 sites.

Conditions

• End-stage Heart Failure

Interventions

Type	Name	Description
DEVICE	HM III
OTHER	OMM, optimal medical management	Patients randomized to OMM will be treated according to international guidelines. All patients should receive a beta blocker, an ACE-inhibitor or an Angiotension II receptor blocker, and a mineralocorticoid receptor antagonist if tolerated and at optimally titrated doses according to guidelines. Loop diuretics should also be used as needed to control fluid retention. Other drugs that may relieve symptoms and improve prognosis can be used (incl ivabradin, digoxin, hydralazine,isosorbiddinitrate, anticoagulant agents). Patients that have an indication for implantable cardioverter defibrillator (ICD) and/or cardiac resynchronization therapy (CRT) should receive such therapy. Surgical interventions that may be indicated for specific underlying or contributing causes of heart failure.

Timeline

• Start date: 2016-06-01
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2015-10-30
• Last updated: 2023-04-26

Locations

7 sites across 1 country: Sweden