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COMPLETED NA

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

NCT01121107 · View on ClinicalTrials.gov ↗

Study 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).

Conditions Studied

Interventions

  • DEVICE Left Atrial Pressure Monitoring System
  • DEVICE Patient Advisory Module

Study Locations (20)

California

  • St. Jude Hospital — Fullerton
  • Glendale Memorial Hospital and Medical Center — Glendale
  • Scripps Green Hospital — La Jolla
  • USC University Hospital — Los Angeles
  • Cedars-Sinai Medical Center — Los Angeles
  • VA Palo Alto Medical Center — Palo Alto
  • Sutter Memorial Hospital — Sacramento
  • University of California at San Francisco — San Francisco
  • Pacific Heart Institute — Santa Monica
  • Radiant Research — Santa Rosa

Florida

  • Shands Jacksonville — Jacksonville
  • Tampa General Hospital — Tampa

Georgia

  • The Emory Clinic - Crawford Long Hospital — Atlanta
  • St. Joseph's Hospital — Atlanta

Illinois

  • Northwestern Memorial Hospital — Chicago
  • Advocate Health and Hospitals Corporation — Oakbrook Terrace

Arizona

  • Cardiovascular Consultants Ltd — Phoenix

Iowa

  • Iowa Heart Center — Des Moines

Kansas

  • Mid-America Cardiology Associates, PC — Kansas City

Kentucky

  • University of Kentucky — Lexington

Trial Details

FieldValue
Enrollment Target 486 participants
Start Date 2010-04
Est. Completion 2015-04
Phase NA

Sponsor

Abbott Medical Devices

155 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01121107

The ClinicalTrials.gov registry entry for NCT01121107 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 486 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which Left Atrial Pressure Monitoring System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01121107 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01121107 about?

NCT01121107 is a clinical study titled "Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy". 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...

What is the current status of trial NCT01121107?

This trial is currently completed. It is a NA study. The enrollment target is 486 participants. The study started on 2010-04. Estimated completion is 2015-04.

What conditions does trial NCT01121107 study?

This clinical trial studies the following conditions: Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01121107?

The interventions under investigation include: Left Atrial Pressure Monitoring System (DEVICE), Patient Advisory Module (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01121107?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01121107 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial