Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

Heart Failure Clinical Trial

— LAPTOP-HF  

Official title:

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121107
• Other study ID #: G090084
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: April 2015

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

• 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Left Atrial Pressure Monitoring System
Left atrial lead is placed for ambulatory monitoring of left atrial pressure
• Patient Advisory Module
Handheld device that provides medication reminders

Locations

Country	Name	City	State
New Zealand	Christchurch Hospital	Christchurch
United States	Northeast Ohio Cardiovascular	Akron	Ohio
United States	Trinity Health - Michigan d/b/a Michigan Heart	Ann Arbor	Michigan
United States	St. Joseph's Hospital	Atlanta	Georgia
United States	The Emory Clinic - Crawford Long Hospital	Atlanta	Georgia
United States	Austin Heart	Austin	Texas
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Sanger Clinic	Charlotte	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	The Linder Center	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	VA Medical Center Cleveland	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Iowa Heart Center	Des Moines	Iowa
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Jude Hospital	Fullerton	California
United States	Glendale Memorial Hospital and Medical Center	Glendale	California
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Hermann Hospital	Houston	Texas
United States	Methodist Hospital Research Institute	Houston	Texas
United States	Texas Heart Institute	Houston	Texas
United States	Shands Jacksonville	Jacksonville	Florida
United States	Mid-America Cardiology Associates, PC	Kansas City	Kansas
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Scripps Green Hospital	La Jolla	California
United States	Lancaster Heart Foundation	Lancaster	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	Bryan LGH Heart Institute	Lincoln	Nebraska
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	MidMichigan Physicians Group	Midland	Michigan
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Intermountain Heart Rhythm Specialists	Murray	Utah
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	University of Medicine & Dentistry of New Jersey	Newark	New Jersey
United States	Sentara Hospitals and Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Advocate Health and Hospitals Corporation	Oakbrook Terrace	Illinois
United States	McKay-Dee Heart Services	Ogden	Utah
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	VA Palo Alto Medical Center	Palo Alto	California
United States	Cardiovascular Consultants Ltd	Phoenix	Arizona
United States	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Providence Heart and Vascular Institute	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	Beaumont Hospital, Royal Oak	Royal Oak	Michigan
United States	Sutter Memorial Hospital	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California at San Francisco	San Francisco	California
United States	Pacific Heart Institute	Santa Monica	California
United States	Radiant Research	Santa Rosa	California
United States	Tampa General Hospital	Tampa	Florida
United States	University of Massachusettts Medical Center	Worcester	Massachusetts
United States	Main Line Health Heart Center: Lankenau Hospitals	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	event driven