The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart failure. The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current HF status, similar to the manner in which diabetes patients manage their insulin therapy. The goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart failure (HF) and hospitalizations in patients who are managed with the left atrial pressure (LAP) management system (treatment group) versus those who receive only the current standard of care (control group).
The Sponsor believes that direct measurements from your heart may provide an accurate, reliable and medically acceptable way of better managing your heart failure prior to your noticing symptoms or being hospitalized. This may enable you and your doctor to take preventative measures, by fine tuning your care including more frequently adjusting your medications with a goal of avoiding hospitalization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
486
Left atrial lead is placed for ambulatory monitoring of left atrial pressure
Handheld device that provides medication reminders
Cardiovascular Consultants Ltd
Phoenix, Arizona, United States
St. Jude Hospital
Fullerton, California, United States
Glendale Memorial Hospital and Medical Center
Glendale, California, United States
Scripps Green Hospital
La Jolla, California, United States
USC University Hospital
Los Angeles, California, United States
Freedom from study-related major adverse cardiovascular and neurological events (MACNE)
Safety will be demonstrated by evaluating the freedom from study-related (procedure or device) major adverse cardiovascular and neurological events (MACNE) in the Treatment group at 12 months from Randomization. The secondary safety endpoint is a non-inferiority analysis of the relative risk (RR) of All-Cause MACNE between the Treatment group and the Control group.
Time frame: 12 months
Reduction in Relative Risk of Heart Failure Hospitalization
Effectiveness will be determined by evaluating the reduction in the relative risk (RRR) of Heart Failure MACNE between the Treatment and Control groups from randomization. The secondary effectiveness endpoints are days alive and out of the hospital for HF through 12 months after the randomization and all-cause death at 12 months from the randomization.
Time frame: event driven
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Cedars-Sinai Medical Center
Los Angeles, California, United States
VA Palo Alto Medical Center
Palo Alto, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
University of California at San Francisco
San Francisco, California, United States
Pacific Heart Institute
Santa Monica, California, United States
...and 54 more locations