Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol

Journal of Heart and Lung Transplantation

Volumn 35, Issue 4, 2016, Pages 528-536

  Heatley, Gerald ^a   Sood, Poornima ^a   Goldstein, Daniel ^b   Uriel, Nir ^c   Cleveland, Joseph ^d   Middlebrook, Don ^a   Mehra, Mandeep R ^e  

^a St Jude Medical   (United States)

^b MONTEFIORE MEDICAL CENTER   (United States)

^c UNIVERSITY OF CHICAGO   (United States)

^d UNIVERSITY OF COLORADO   (United States)

^e BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

advanced heart failure; HeartMate 3; LVAD; MagLev; MOMENTUM 3

Indexed keywords

ARTICLE; ASSISTED CIRCULATION; BLEEDING; CEREBROVASCULAR ACCIDENT; CLINICAL ASSESSMENT; CLINICAL PROTOCOL; COHORT ANALYSIS; CONTROLLED STUDY; DEVICE INFECTION; GASTROINTESTINAL HEMORRHAGE; HEART ARRHYTHMIA; HEART RIGHT VENTRICLE FAILURE; HEMOLYSIS; HUMAN; LEFT VENTRICULAR ASSIST DEVICE; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MEDICAL DEVICE COMPLICATION; MULTICENTER STUDY; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROSTHESIS FAILURE; PROSTHESIS THROMBOSIS; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; REOPERATION; RESPIRATORY FAILURE; RIGHT VENTRICULAR ASSIST DEVICE; SEPSIS; STUDY DESIGN; TRANSCATHETER AORTIC VALVE IMPLANTATION; WOUND DEHISCENCE; EQUIPMENT DESIGN; HEART ASSIST DEVICE; HEART FAILURE; MULTICENTER STUDY (TOPIC); PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC);

CLINICAL PROTOCOLS; EQUIPMENT DESIGN; HEART FAILURE; HEART-ASSIST DEVICES; HUMANS; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84962136646     PISSN: 10532498     EISSN: 15573117     Source Type: Journal    
DOI: 10.1016/j.healun.2016.01.021     Document Type: Article

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