CVCRI Clinical Trials

Sponsor: Endotronix
A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II-III Heart Failure Patients
(PROACTIVE-HF-2 Trial)

Cordella PA Sensor System
The Cordella PA Sensor System is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class II-III heart failure patients at home to clinicians for assessment and patient centered heart failure management, with the goal of reducing heart failure hospitalizations.

Study Objectives:
Randomized Arm
To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data.

Single Arm
To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a sub-study with a clinician-directed patient self-management strategy.

Sponsor: Abiomed

Superior VENa Caval OcclUSion in Subjects with Acute Decompensated Heart Failure (VENUS-HF): An Early Feasibility Study

Study Design:
A prospective, open-label, multicenter early feasibility study (EFS) designed to confirm the safety and performance of the preCARDIA™ System

Objectives:
To evaluate the safety and performance of the preCARDIA System for superior vena caval (SVC) intermittent mechanical occlusion as a therapeutic approach in significantly congested subjects with acute decompensated heart failure (ADHF). After previously confirming neurological and hemodynamic safety in a short-term pre-feasibility study on eight (8) subjects, our aim is to now confirm safety of the transient SVC occlusion approach in the target population for 24 hours. In addition, we will study and measure the acute hemodynamic changes associated with the treatment, including changes in right atrial, pulmonary arterial and pulmonary capillary wedge pressures, as well as urine output and subject’s response in terms of heart failure symptoms.

Test Device:
The preCARDIA System which consists of two (2) parts: A balloon occlusion catheter (BOC) with tubing set and a pump console (PC). 
 

The preCARDIA System which consists of two (2) parts: A balloon occlusion catheter (BOC) with tubing set and a pump console (PC).