News | June 22, 2010

St. Jude Medical Announces First Enrollment in Heart Failure Management Trial

June 22, 2010 – St. Jude Medical Inc. last week announced the first enrollment in its LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) study. The goal of the LAPTOP-HF study is to demonstrate that the new investigational left atrial pressure (LAP) management system safely and effectively improves outcomes in patients with heart failure (HF). The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current LAP, similar to the manner in which diabetes patients manage their insulin therapy.

Clinicians commonly use the symptoms of HF, such as fatigue or shortness of breath, to determine a patient’s HF status and subsequent treatment. However, changes in HF symptoms are difficult to gauge and may be caused by other conditions. LAP provides a more objective measure of left-sided hemodynamics, which helps to assess HF status. Changes in LAP precede development of pulmonary edema (fluid in the lungs) and result in worsening HF symptoms.

The LAPTOP-HF trial is a 700 patient randomized, controlled, prospective, multi-center clinical investigation to evaluate the safety and effectiveness of the LAP HF management system. Currently, there is no means of measuring LAP outside the hospital setting.

The first enrollment was performed by a multidisciplinary team including the Principal Investigators, Dr. Leway Chen, a heart failure specialist, and Dr. Spencer Rosero, a cardiac electrophysiologist, both from the University of Rochester Medical Center in Rochester, New York. Commenting on the trial, Dr. Chen said, “This system has the potential to bring left atrial pressure monitoring to the outpatient setting, which I believe will ultimately empower patients to take more control in the management of their condition.”

Physician-directed, patient self-management, which has become standard in diabetes management, is a new approach for HF management. It may provide physicians the ability to better personalize and optimize HF management on the basis of daily, objective measures of a patient’s HF status. By providing patients with daily feedback on their LAP status and automated prescription instructions, it may also encourage self-management and treatment adherence in a more efficient manner than possible with traditional heart failure management approaches.

Related Content

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Heart Failure Market to Surpass $16 Billion by 2026
News | Heart Failure| September 19, 2017
The heart failure space across the seven key markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
Overlay Init