Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT02592499
NA

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

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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.

Official title: Swedish Evaluation of Left Ventricular Assist Device

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2016-06

Completion Date

2026-12

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

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.

Locations (7)

Sahlgrenska Univesitetssjukhustet, Transplantationscentrum

Gothenburg, Sweden

Linköping Univ Hospital

Linköping, Sweden

Skåne University Hospital

Lund, Sweden

Örebro Univ Hospital

Örebro, Sweden

Karolinska Univ Hospital

Stockholm, Sweden

Univ Hospital of Umeå

Umeå, Sweden

Uppsala Univ Hospital

Uppsala, Sweden