This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure. The primary endpoint is survival at 6 months presented as a simple proportion (subjects alive on the MVAD® pump divided by endpoint eligible subjects). Secondary endpoints include the incidence of bleeding, incidence of major infections (per INTERMACS definitions), time to death, incidence of all device failures and device malfunctions, Health Status improvement, and Functional status improvement. Safety measures will include the frequency and rates of adverse events, overall and for each specific event, which will be collected throughout VAD support.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system
St. Vincents Hospital
Darlinghurst, Australia
Medical University AKH Vienna
Vienna, Austria
Hospitalier Pitié-Salpétrière
Paris, France
Survival
Primary Endpoint: survival at 6 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 6 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
Time frame: Six month
Survival
Survival at 24 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 24 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
Time frame: Two years
Survival: Number of Participants Who Died by Six Months and Two Years
Survival: Number of participants who died by six months and two years
Time frame: Six months and two years
Incidence of Major Bleeding
Incidence of major bleeding, per INTERMACS definition
Time frame: Six months and two years
Incidence of All Device Failures and Device Malfunctions
Incidence of all device failures and device malfunctions per INTERMACS definition
Time frame: Six months and two years
Incidence of Major Infection
Incidence of major infection, per INTERMACS definition
Time frame: Six months and two years
Incidence of Neurological Dysfunction
Incidence of neurological dysfunction per INTERMACS definition
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Heart and Diabetes Center NRW
Bad Oeynhausen, Germany
German Heart Institute Berlin DHZB
Berlin, Germany
Duesseldorf University Hospital
Düsseldorf, Germany
Uniklinik Hamburg Eppendorf (UKE)
Hamburg, Germany
Hannover Medical School MHH
Hanover, Germany
University of Leipzig Heart Center
Leipzig, Germany
Freeman Hospital
Newcastle upon Tyne, United Kingdom
...and 1 more locations
Time frame: Six months and two years
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
Health Status change, as measured by KCCQ and EuroQol EQ-5D-5L. Measured at baseline, 6 month visit and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured. The EQ-5D-5L overall score is between 0 and 1. 1 being the best score and 0 being the worst score. The KCCQ score is between 0 and 100. 100 being the best score and 0 being the worst score.
Time frame: Six month and 24 month visit
Functional Status Change, as Measured 6-minute Walk
Functional status change, as measured by 6-minute walk. Distance walked in meters in 6 minutes measured at baseline, 6 months and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured
Time frame: 6 month and 24 month visit
Frequency and Rates of Adverse Events(AEs)
Frequency and rates of adverse events(AEs) throughout VAD support per INTERMACS Definition
Time frame: Six months and two years
Length of Initial Hospital Stay (Days)
Length of Initial hospital stay (days) from procedure start to discharge
Time frame: Post operation
Re-Hospitalizations
The length of Re-Hospitalization, excluding planned procedures, stay in days.
Time frame: On or before 6 months follow-up and 24 month follow-up
Transplantations
Transplantations of subjects enrolled in study and implanted with MVAD System
Time frame: Six months and two years
Explants
Explants (i.e. death, transplant, recovery, device exchange) of MVAD in subjects enrolled in study and implanted with MVAD System
Time frame: Six months and two years
New York Heart Association (NYHA) Functional Classification Score
NYHA score measured at baseline, 6 month visit and 24 month visit. The NYHA scale is from I to IV. A subject with a score of IV indicates more severe heart failure than a subject with a score of I. Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort
Time frame: Baseline and 6 month and 24 month visit
Length of Operative Time (Hours)
Length of operative time (hours)
Time frame: Implant