Heart FailureLAPTOP-HFNCT01121107
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
A study testing Left Atrial Pressure Monitoring System and Patient Advisory Module in people with Heart Failure, run by Abbott Medical Devices at 64 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Left Atrial Pressure Monitoring System and Patient Advisory Module
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 64 sitesin 2 countries
- Study dates
- Apr 2010to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Are under the age of 18 years.
- Are pregnant.
- Have intractable HF with resting symptoms despite maximal medical therapy (persistent NYHA Class IV and ACC/AHA HF Stage D). This includes patients receiving continuous or intermittent outpatient intravenous vasoactive medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular assist device (VAD), and patients who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months - even if their functional status has improved to NYHA Class III. Patients listed for cardiac transplantation who are not likely to be transplanted within 12 months and who have improved to NYHA Class III without outpatient IV vasoactive medications or a VAD are eligible for the study, if they meet the other inclusion/exclusion criteria.
- 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.
Show all 22Show fewer
- 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.
- Have a life expectancy < 1 year due to another illness.
- Have coagulopathy or uninterruptible anticoagulation therapy or contraindication for all of the forms of antiplatelet/anticoagulant treatments anticipated in the protocol.
- Have an Estimated Glomerular Filtration Rate that remains < 30 ml/min/1.73 M2 by the MDRD method.
- Have a Liver Function Test > 3 times upper limit of normal.
- Have Severe Pulmonary Disease producing frequent hospitalizations for respiratory distress and requiring continuous home oxygen.
- Have pulmonary hypertension with a pulmonary artery systolic pressure of greater than or equal to 80 mm/Hg on screening echocardiogram.
- Have an active infection requiring systemic antibiotics.
- Have a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
- Are currently participating in a clinical investigation that includes an active treatment arm.
- Are unable to demonstrate understanding and capability of using the PAM patient advisory module appropriately.
- Patient does not have access to a telephone line usable for remote PAM follow-up or electrical outlet for recharging PAM.
Trial locations and contacts
64 sites in 2 countries.
64 sites in 2 countries
United States63 sites
Northeast Ohio Cardiovascular
Akron, Ohio, 44304
Trinity Health - Michigan d/b/a Michigan Heart
Ann Arbor, Michigan, 48104
The Emory Clinic - Crawford Long Hospital
Atlanta, Georgia, 30308
St. Joseph's Hospital
Atlanta, Georgia, 30324
Austin Heart
Austin, Texas, 78703
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29403
Sanger Clinic
Charlotte, North Carolina, 29601
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60565
The Linder Center
Cincinnati, Ohio, 45227
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
VA Medical Center Cleveland
Cleveland, Ohio, 44202
Ohio State University
Columbus, Ohio, 43210
Iowa Heart Center
Des Moines, Iowa, 50314
Duke University Medical Center
Durham, North Carolina, 27710
St. Jude Hospital
Fullerton, California, 92629
Glendale Memorial Hospital and Medical Center
Glendale, California, 91204
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17603
Memorial Hermann Hospital
Houston, Texas, 77030
Methodist Hospital Research Institute
Houston, Texas, 77030
Texas Heart Institute
Houston, Texas, 77030
Shands Jacksonville
Jacksonville, Florida, 32209
Mid-America Cardiology Associates, PC
Kansas City, Kansas, 66160
St. Luke's Hospital
Kansas City, Missouri, 64111
Scripps Green Hospital
La Jolla, California, 92037
Lancaster Heart Foundation
Lancaster, Pennsylvania, 17603
University of Kentucky
Lexington, Kentucky, 40515
Bryan LGH Heart Institute
Lincoln, Nebraska, 68506
USC University Hospital
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Jewish Hospital
Louisville, Kentucky, 40202
Baptist Memorial Hospital
Memphis, Tennessee, 38120
MidMichigan Physicians Group
Midland, Michigan, 48640
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53201
Minneapolis Heart Institute
Minneapolis, Minnesota, 55410
Morristown Memorial Hospital
Morristown, New Jersey, 07940
Intermountain Heart Rhythm Specialists
Murray, Utah, 80134
Vanderbilt Medical Center
Nashville, Tennessee, 37212
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
Ochsner Medical Center
New Orleans, Louisiana, 70121
University of Medicine & Dentistry of New Jersey
Newark, New Jersey, 07940
Sentara Hospitals and Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois, 60181
McKay-Dee Heart Services
Ogden, Utah, 84403
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
VA Palo Alto Medical Center
Palo Alto, California, 95054
Cardiovascular Consultants Ltd
Phoenix, Arizona, 85032
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
Providence Heart and Vascular Institute
Portland, Oregon, 97225
University of Rochester
Rochester, New York, 14642
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48314
Sutter Memorial Hospital
Sacramento, California, 95819
University of California at San Francisco
San Francisco, California, 94143
Pacific Heart Institute
Santa Monica, California, 90404
Radiant Research
Santa Rosa, California, 95054
Washington University School of Medicine
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
University of Massachusettts Medical Center
Worcester, Massachusetts, 01655
Main Line Health Heart Center: Lankenau Hospitals
Wynnewood, Pennsylvania, 19096
About this study
Official title: Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study
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).
Read the 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
- Being tested
- Left Atrial Pressure Monitoring System, Patient Advisory Module
- Keywords
- Heart Failure, Decompensated Heart Failure, Acute Decompensated Heart Failure, Hemodynamic Monitoring, Implantable Pressure Monitor, Left Atrial Pressure Monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Pressure Monitoring SystemDevice
Left atrial lead is placed for ambulatory monitoring of left atrial pressure
Patient Advisory ModuleDevice
Handheld device that provides medication reminders
| Study group | Role | What they receive |
|---|---|---|
| Left Atrial Pressure Monitoring System | Experimental | Left Atrial Pressure (LAP) Monitoring System Receives: Device: Left Atrial Pressure Monitoring System; Device: Patient Advisory Module |
| Patient Advisor Module | Active comparator | Patient Advisory Module Receives: Device: Patient Advisory Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: event driven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leway Chen, M.D., Principal investigator, University of Rochester, Strong Memorial Hospital, Rochester, NYLeslie Saxon, M.D., Principal investigator, USC University Hospital, Los Angeles, CAJohn P. McKenzie III, MD, Principal investigator, Glendale Memorial Hospital and Medical Center, Glendale, CASteven Bailin, MD, Principal investigator, Iowa Heart Center, Des Moines, IADhanunjaya Lakkireddy, MD, Principal investigator, Mid-America Cardiology Associates, PC, Kansas City, KSHamang Patel, MD, Principal investigator, Ochsner Health SystemAyesha Hasan, MD, Principal investigator, Ohio State UniversityPhilip B. Adamson, MD, Principal investigator, Oklahoma Cardiovascular Research Group, Oklahoma City, OK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121107
- Sponsor's protocol ID
- G090084
- Acronym
- LAPTOP-HF
- Status last verified
- Jul 2023
- First submitted
- 5 May 2010
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study
- ClinicalTrials.gov ID
- NCT01121107
- Acronym / sponsor ID
- LAPTOP-HF / G090084
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Decompensated Heart Failure, Acute Decompensated Heart Failure, Hemodynamic Monitoring, Implantable Pressure Monitor, Left Atrial Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Atrial Pressure Monitoring System | Experimental | Device: Left Atrial Pressure Monitoring System, Device: Patient Advisory ModuleLeft Atrial Pressure (LAP) Monitoring System |
| Patient Advisor Module | Active comparator | Device: Patient Advisory ModulePatient Advisory Module |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- Are under the age of 18 years.
- Are pregnant.
- Have intractable HF with resting symptoms despite maximal medical therapy (persistent NYHA Class IV and ACC/AHA HF Stage D). This includes patients receiving continuous or intermittent outpatient intravenous vasoactive medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular assist device (VAD), and patients who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months - even if their functional status has improved to NYHA Class III. Patients listed for cardiac transplantation who are not likely to be transplanted within 12 months and who have improved to NYHA Class III without outpatient IV vasoactive medications or a VAD are eligible for the study, if they meet the other inclusion/exclusion criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Atrial Pressure Monitoring SystemLeft atrial lead is placed for ambulatory monitoring of left atrial pressure | Device | Left Atrial Pressure Monitoring System |
| Patient Advisory ModuleHandheld device that provides medication reminders | Device | Left Atrial Pressure Monitoring System, Patient Advisor Module |
Primary outcome
Freedom from study-related major adverse cardiovascular and neurological events (MACNE)
Time frame: 12 months
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.
Reduction in Relative Risk of Heart Failure Hospitalization
Time frame: event driven
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leway Chen, M.D. principal investigator
University of Rochester, Strong Memorial Hospital, Rochester, NY
Leslie Saxon, M.D. principal investigator
USC University Hospital, Los Angeles, CA
John P. McKenzie III, MD principal investigator
Glendale Memorial Hospital and Medical Center, Glendale, CA
64 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Atrial Pressure Monitoring System and Patient Advisory Module in people with Heart Failure, run by Abbott Medical Devices at 64 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from study-related major adverse cardiovascular and neurological events (MACNE) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.