NCT01121107

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Left Atrial Pressure Monitoring System	Left atrial lead is placed for ambulatory monitoring of left atrial pressure
DEVICE	Patient Advisory Module	Handheld device that provides medication reminders

Timeline

• Start date: 2010-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2010-05-12
• Last updated: 2023-07-21

Locations

64 sites across 2 countries: United States, New Zealand