CardioMEMSTM HF System Post Approval Study
RATIONALE: Heart failure is a major cause of morbidity and mortality. CardioMEMS HF System is an FDA approved implantable device that wirelessly measures and monitors pulmonary arterial pressure and heart rate. The CHAMPION trial demonstrated that management of heart failure using pulmonary artery pressure information obtained with the CardioMEMS HF System, in addition to traditional signs and symptoms, reduced HF hospitalizations.
INTERVENTION: Patients will be scheduled for follow-up visits at 1 month and every 6 months for 2 years. Following sensor implant and hospital discharge, subjects will take PA pressure measurements on a daily basis, or as directed by the investigator. These measurements will be automatically transmitted to the secure Patient database (CardioMEMS HF website).
OBJECTIVES: The objective of this study is to confirm the post-market safety and effectiveness of the CardioMEMS HF System to premarket.
STUDY POPULATION: Twelve hundred subjects will be enrolled with at least 35% of the enrolled patients being women (420 women out of 1200). Enrollment will be limited to 15% of the total study population at any one site.
STUDY METHODOLOGY: This is a prospective, multi-center, open-label trial conducted in the United States (US). All subjects who sign the informed consent form and satisfy the inclusion/exclusion criteria will be enrolled into the CardioMEMS HF System PAS and will be scheduled for follow-up visits at 1 month and every 6 months for 2 years. Following sensor implant and hospital discharge, subjects will take PA pressure measurements on a daily basis, or as directed by the investigator. These measurements will be automatically transmitted to the secure Patient database (CardioMEMS HF website).
STUDY ENDPOINTS:Primary safety endpoints will be evaluated at 2 years: 1) freedom from device/system related complications and 2) freedom from pressure sensor failure.
STATISTICS: The primary safety hypotheses are that the device / system-related complication-free proportion of subjects will be at least 80% at 24 months (OPC used in the CHAMPION trial) and that the pressure sensor failure-free proportion of subjects will be at least 90% at 24 months (OPC used in the CHAMPION trial). Plotting and analysis of safety endpoints will also be displayed using Kaplan-Meier methods. All safety analyses will be performed on the safety population.
An Open-Label, Multicenter, Historically-Controlled Study to Assess Safety and Efficacy of ELAD in Subjects With Acute Liver Failure (ALF)
VTI-212 is an open-label, multicenter, historically-controlled study of subjects with acute
liver failure (ALF). Approximately 40 subjects who meet the eligibility requirements of the
study will receive ELAD treatment in addition to standard of care treatment for ALF. The
outcomes of these subjects will be compared with matched historical controls drawn from
Subjects will undergo ELAD treatment for a minimum of 3 days (72 hours). It is recommended
ELAD treatment be continued up to 10 days (240 hours).
Following ELAD treatment, subjects will continue standard medical therapy as defined by the
institution and be followed through Study Day 28.
Subjects' diagnosis of ALF will be attributed to one of the following:
1. FHF (acute liver failure with no preexisting liver disease);
2. Primary Graft Non-Function (PNF);
3. Surgically-Induced Liver Failure (including subjects with small for size liver
transplants, living donor liver transplants, and subjects with risk of ALF following
liver cancer surgery.
Screening evaluations and assessments will be completed for subjects and reviewed against
Enrollment will define the time of study entry (Hour 0, Study Day 1, study baseline) and
inclusion in the ITT population. Subjects will be evaluated throughout the 28-day study
If standard medical therapy, as defined by the institution and this protocol is consistent
with discharging the subject home, then the subject should be discharged. Prior to
discharge, the subject will be advised to attend all follow-up visits.
An extension of this study, VTI-212E, will provide additional ELAD survival data, as
available, through VTI-212 study termination (after the last surviving enrolled ELAD subject
completes Study Day 28). This registry protocol segment of VTI-212 extends the safety
monitoring period to 5 years to assess survival, incidence and characterization of tumor (in
particular hepatocellular tumor), incidence of liver transplant, and assess quality of life
using a standard, validated questionnaire.
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
Evidence supporting a routine invasive practice paradigm for patients with stable ischemic
heart disease (SIHD) is outdated. In strategy trials conducted in the 1970s, coronary artery
bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with
high-risk anatomic features. The relevance of these studies today is speculative because
contemporary secondary prevention—aspirin, beta-blockers, statins, ACE inhibitors, and
lifestyle interventions—were used minimally if at all. Subsequent trials have compared
percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as
the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce
death or myocardial infarction (MI) compared with medical therapy in SIHD patients.
COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical
therapy in SIHD patients, found that among patients selected on the basis of coronary
anatomy after cath, an initial management strategy of coronary revascularization (PCI, PCI
or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or
death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine
cath--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be
required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had
ischemia level documented at baseline had only mild or moderate ischemia, leaving open the
question of the appropriate role of cath and revascularization among higher risk patients
with more severe ischemia. Observational data suggest that revascularization of patients
with moderate-to-severe ischemia is associated with a lower mortality than medical therapy
alone, but such data cannot establish a cause and effect relationship. In clinical practice
only about half such patients are referred for cath, indicating equipoise. Furthermore,
analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline
did not reveal a benefit from PCI. This issue cannot be resolved using available data
because all prior SIHD strategy trials enrolled patients after cath, introducing undefined
selection biases (e.g., highest risk patients not enrolled) and making translation of study
results problematic for clinicians managing patients who have not yet had cath.
A clinical trial in SIHD patients uniformly at higher risk (which could not have been
performed before COURAGE and BARI 2D results were available) is needed to inform optimal
management for such patients.
The study protocol is final, and was distributed to sites February 2012. Study protocol v2.0
was approved in January 2014.
- USA (~150 sites)
- Russian Federation
- New Zealand
- Saudi Arabia
Assessing the Efficacy of Secukinumab in Psoriasis Patients
The purpose of the study is to see if secukinumab has an effect on fatty tissue beneath the skin and on skin inflammation in patients with psoriasis. This study will also look at blood tests, or “markers,” that could help identify risk for heart disease and metabolic diseases like diabetes or cardiometabolic disease.
Secukinumab (Cosentyx®) is a prescription medicine that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis in adults.
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The PORTICO IDE trial will include approximately 758 randomized subjects at up to 70
investigational sites. The study is powered to analyze the high risk cohort and extreme risk
cohort together against a commercially available control for the primary safety and
effectiveness endpoints. In addition, data for each cohort will be analyzed separately in a
A minimum of two (2) and up to three (3) roll-in patients per primary implanting physician
will be allowed. These roll-in subjects will be added to a Roll-in Registry. In addition, up
to 100 subjects may be enrolled in a Valve-in-Valve registry. Implanting physicians with
prior Portico experience and with a minimum of 3 implants in the last 6 months will not be
required to include roll-in patients.
Registry data will not be included in the randomized cohort analysis, but will be analyzed
and presented separately.
The FlexNav study will be conducted as a separate arm of the PORTICO IDE trial and will
include 100 high or extreme risk patients. Safety data for the FlexNav™ Delivery System will
be summarized and descriptively compared to the first-generation Portico Delivery System.
Following completion of enrollment in the randomized cohort, subjects will be eligible for
enrollment in the Portico IDE Continued Access Protocol (CAP) Study.
The sponsor will submit a final clinical report for combined risk cohorts as enrollment and
follow-up is completed according to the protocol.
How the diet of breastfeeding Latina moms affects the health of their babies
This study looks at the effects of sugar in Hispanic/Latina moms and their babies. Previous studies have found that eating and drinking too much sugar can cause weight gain and health problems that affect the liver, kidneys, and heart. Feeding sugar to children can cause health problems that affect their growth and development. Hispanic/Latina moms and their babies are more at risk for these health problems than other groups. <strong>We want to find out whether an education program to reduce sugar improves the health of Hispanic/Latina moms and their babies. Come join the MAMITA Study if you are a pregnant or have a newborn.</strong>