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Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy | Clinical Trials | Clareo Health

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Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study

NCT01121107•Abbott Medical Devices

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have ischemic or non-ischemic cardiomyopathy with either a history of reduced or preserved ejection fraction and heart failure for at least 6 months.
•NYHA Class III documented at screening visit.
•Be receiving appropriate medical therapy for heart failure as per ACC/AHA guidelines (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta-blocker) for at least 3 months prior to the randomization visit. Subject has been on stable medications maximized to the subject's tolerance of ACE or ARB and beta-blockers as determined by the study investigator for at least 30 days prior to randomization. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waved if a subject is intolerant of ACE, ARB or beta-blockers, or these agents are not indicated under the Guidelines. Such intolerance or lack of indications must be documented.
•Have a minimum of one (1) prior hospital admission within the last 12 months for acute exacerbation of HF of at least one (1) calendar date change duration requiring intravenous or invasive HF therapy. If CRT device previously implanted, the heart failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if patients have not had a heart failure hospitalization within the prior 12 months, they must have an elevated Brain Natriuretic Peptide (BNP) level of at least 400pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local measurement at the time of screening (within 30 days of the screening visit/consent)
•Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.
•Are able to schedule Therapy Initiation within two weeks. Enrollment/Randomization may be delayed until this criterion is met.

Exclusion Criteria

•Are under the age of 18 years.
•Are pregnant.
•Have a resting systolic blood pressure \< 80 or \> 180 mmHg.
•Have an acute MI, Acute Coronary Syndrome, Percutaneous Coronary Intervention (PCI), new cardiac rhythm management device (Pacemaker, ICD, and CRT), CRM system revision, lead extraction or cardiac or other major surgery within 40 days.
•Have known coexisting, untreated, hemodynamically severe stenotic valve lesions, vegetations, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion.
•Have an Atrial Septal Defect or Patent Foramen Ovale (with more than trace shunting on color Doppler or intravenous bubble study) or surgical correction of significant congenital heart disease involving atrial septum such as PFO or ASD closure device.
•Have a Stroke or Transient Ischemic Attack within 6 months.
•Have inadequate vascular access for device implantation.
•Have baseline 2-D echocardiographic evidence of, or history of, unresolved left atrial or ventricular thrombus.
•Have a recent (within 6 months) or persistent deep venous thrombosis, pulmonary or systemic thromboembolism.
+11 more criteria

Locations (64)

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

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

Key Dates

Start Date

April 1, 2010

Primary Completion Date

April 1, 2015

Completion Date

April 1, 2015

Last Updated

July 21, 2023

Enrollment

486

ACTUAL participants

Conditions

Heart Failure

Interventions

Left Atrial Pressure Monitoring System

DEVICE

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DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

Inclusion Criteria

Exclusion Criteria

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