C-Pulse Heart Assist Device pivOtal stUdy treatiNg paTients With modERate to Severe Heart Failure C-Pulse® System: A Heart Assist Device Pivotal IDE Study
The C-Pulse® System is indicated for use in patients with moderate to severe heart failure
while on optimal heart failure drug and on device therapies. The C-Pulse® System is intended
to relieve the symptoms of heart failure, improve quality of life and cardiac function, and
reduce the need for heart failure hospitalization. It is intended for use in hospital and at
home. It is not intended as a replacement for heart function; it is not life sustaining or
life-supporting therapy. It does not preclude the use of other heart failure therapies, such
as valve surgery, heart transplantation or LVAD.
The Sunshine Heart C-Pulse System is an implantable, non-blood contacting, non-obligatory,
heart assist device. The system provides cardiac assistance through an extra-aortic balloon
Cuff and ECG sense lead connected by means of a Percutaneous Interface Lead (PIL) to an
external pneumatic Driver. The PIL is held secure externally, at the exit site, with a simple
adhesive clip (C-Patch or similar) for immobilization of the external part of the PIL. The
Driver is adjusted using a dedicated notebook computer (Programmer) with specialized
The non-blood contacting feature of the C-Pulse® System also allows the device to be
intermittently turned off as tolerated. This allows the patient freedom for personal hygiene.
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.
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
The HeartMate II (HM II) LVAD is approved by the U.S. Food and Drug Administration (FDA) for
use in destination therapy (DT) patients with New York Heart Association (NYHA) Class IIIB/IV
The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational
study that is designed to evaluate the effectiveness of HM II LVAD support versus optimal
medical management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not
dependent on intravenous inotropic support and who meet the FDA approved indications for HM
II LVAD destination therapy. Subjects will be enrolled in one of two cohorts: OMM or LVAD.
Together with the investigator, the subjects will decide which cohort to enter into at their
baseline visit. This study will include experienced HM II LVAD implant centers as well as
community centers that care for a large volume of heart failure patients. Study patients will
be followed for up to 24 months post enrollment for survival, quality of life and functional
Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk
This is a randomized (the study medication is assigned by chance), double-blind (neither
physician nor participant knows the identity of the assigned treatment), placebo (an inactive
substance that is compared with a drug to test whether the drug has a real
effect)-controlled, event-driven, multicenter study in patients who are hospitalized for a
specific acute medical illness and have other risk factors for venous thromboembolism (VTE).
The study is designed to evaluate rivaroxaban in the prevention of symptomatic VTE events and
VTE-related deaths for a period of 45 days post-hospital discharge. The study will consist of
a screening phase, a 45-day double-blind treatment phase, and a 30-day follow-up phase. Study
drug will start at randomization (Day 1), and will continue until Day 45 (inclusive). A total
of approximately 12000 patients will be randomly assigned to either rivaroxaban or placebo in
a 1:1 ratio. The total duration for a patient who completes the study after randomization is
expected to be 75 days.