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NCT01121107 · ClinicalTrials.gov registry record · NA
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
A NA study of Heart Failure, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 486
- Enrollment target
- 20
- Study locations
NCT01121107: Completed NA study of Heart Failure, sponsored by Abbott Medical Devices.
NCT01121107 is a NA study of Heart Failure that has completed, run by Abbott Medical Devices. The registered enrollment target is 486 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01121107, a NA study of Heart Failure, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 486 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2010-04 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01121107 record still lists
NCT01121107 is an interventional study that assigns participants to a tested intervention. The registered 486 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (76% lower).
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.
NCT01121107 names 20 study sites across 8 states, led by California, Florida, Georgia.
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.
What interventions are being tested in trial NCT01121107?
The interventions under investigation include: Left Atrial Pressure Monitoring System (DEVICE), Patient Advisory Module (DEVICE).
Who is sponsoring clinical trial NCT01121107?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01121107's enrollment target sits among peer trials
486 107th of 397 higher than 291 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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