LVP-1000 clinical studies

Transoma Medical is currently conducting two clinical studies designed to evaluate the company's LVP-1000^* Left Ventricular Pressure Monitoring System. The patient populations being studied include those implanted with a left ventricular assist device and patients with advanced heart failure who are scheduled for an open chest procedure.

VALAD study for ventricular assist device patients

This is a non-randomized, prospective, multi-center pilot study which evaluates the feasibility of using the LVP-1000 Left Ventricular Pressure Monitoring System in patients with an implanted ventricular assist device. Patients in the study are in end-stage heart failure — New York Heart Association (NYHA) Class IV — and are scheduled to receive a VAD intended as a bridge to cardiac transplant.

LVP-HF study for open chest patients

This is a non-randomized, prospective, multi-center pilot study conducted to gain preliminary clinical experience using the LVP-1000 Left Ventricular Pressure Monitoring System in patients with advanced heart failure. Patients in the study will be in end-stage heart failure — New York Heart Association (NYHA) Class III or IV — and are scheduled for an open chest procedure (CABG or valve).

How to participate

For more information on how to participate or refer a potential subject in the VALAD or LVP-HF Trial, call Transoma Medical at 651-481-7444. Or contact the Clinical Affairs Coordinator at dcrane@transomamedical.com

^* Limited to investigational use. Not available for sale in the U.S.

Scientific articles/presentations

Extensive pre-clinical work on Transoma's Left Ventricular Pressure Monitoring System has been presented at scientific meetings and in major scientific journals.

Pre-clinical study results

Numerous animal studies were performed during the research and design phase of the LVP-1000 to facilitate the refinement of the device.