CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Left Ventricular Assist System (LVAS)device
Likely dose
Left Ventricular Assist System (LVAS) implantation for hemodynamic supportAI-extracted
Key inclusion· 5
  • ✓Advanced heart failure symptoms NYHA Class IIIB or IV
  • ✓On optimal medical management and failing to respond, OR in Class III/IV heart failure dependent on IABP and/or inotropes, OR intolerant to ACE inhibitors or beta-blockers
  • ✓Ineligible for cardiac transplant
  • ✓VO2max ≤14 ml/kg/min
Key exclusion· 5
  • ✕Evidence of or risk factors for end-organ dysfunction that would make LVAS implantation futile
  • ✕Factors that would adversely affect patient survival or function of the LVAS
  • ✕Intolerance to anticoagulant or antiplatelet therapies
  • ✕Ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00121485
NCT00121485N/ACompleted
CompareCT.gov

The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy

Abbott Medical Devices·interventional·Posted Jul 21, 2005·Updated Jun 27, 2022

In Brief

A clinical study evaluating Left Ventricular Assist System (LVAS) for Heart Failure, Congestive and 2 related conditions. Completed, enrolled 200 participants across 47 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
CountriesCanada, United States
CollaboratorsThoratec Corporation

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2005
Enrollment StartFeb 1, 2005
Primary CompletionJun 1, 2009
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.9 years ago

Interventions

Left Ventricular Assist System (LVAS)device

Implantation of left ventricular assist device for hemodynamic support