Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

NCT ID: NCT01121107

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 486 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-04-30

Brief 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Left Atrial Pressure Monitoring System

Left Atrial Pressure (LAP) Monitoring System

Group Type: EXPERIMENTAL

Left Atrial Pressure Monitoring System

Intervention Type: DEVICE

Left atrial lead is placed for ambulatory monitoring of left atrial pressure

Patient Advisory Module

Intervention Type: DEVICE

Handheld device that provides medication reminders

Patient Advisor Module

Patient Advisory Module

Group Type: ACTIVE_COMPARATOR

Patient Advisory Module

Intervention Type: DEVICE

Handheld device that provides medication reminders

Interventions

Left Atrial Pressure Monitoring System

Left atrial lead is placed for ambulatory monitoring of left atrial pressure

Intervention Type: DEVICE

Patient Advisory Module

Handheld device that provides medication reminders

Intervention Type: DEVICE

Eligibility Criteria

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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leway Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester, Strong Memorial Hospital, Rochester, NY

Leslie Saxon, M.D.

Role: PRINCIPAL_INVESTIGATOR

USC University Hospital, Los Angeles, CA

John P. McKenzie III, MD

Role: PRINCIPAL_INVESTIGATOR

Glendale Memorial Hospital and Medical Center, Glendale, CA

Steven Bailin, MD

Role: PRINCIPAL_INVESTIGATOR

Iowa Heart Center, Des Moines, IA

Dhanunjaya Lakkireddy, MD

Role: PRINCIPAL_INVESTIGATOR

Mid-America Cardiology Associates, PC, Kansas City, KS

Hamang Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Ayesha Hasan, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Philip B. Adamson, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Cardiovascular Research Group, Oklahoma City, OK

Steve Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Shands Jacksonville, Jacksonville, FL

John Ferguson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Medical Center, Charlottesville, VA

Steven Krueger, MD

Role: PRINCIPAL_INVESTIGATOR

Bryan LGH Heart Institute, Lincoln, NE

Andrew Civitello, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Heart Institute, Houston, TX

Theo Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Medical Center, Worcester, MA

Stephen W Halpern, MD

Role: PRINCIPAL_INVESTIGATOR

Radiant Research, Santa Rosa, CA

Rami Alharethi, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Heart Rhythm Specialists, Murray, UT

Otfried Neidermaier, MD

Role: PRINCIPAL_INVESTIGATOR

Northeast Ohio Cardiovascular Specialists, Akron, OH

Marlo Leonen, MD

Role: PRINCIPAL_INVESTIGATOR

Trinity Health-Michigan d/b/a Michigan Heart, Ann Arbor, MI

Peter Pak, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Heart Institute, Santa Monica, CA

Maria Rosa Costanzo, MD

Role: PRINCIPAL_INVESTIGATOR

Advocate Health and Hospitals Corporation, Oakbrook Terrace, IL

Nasir Sulemanjee, MD

Role: PRINCIPAL_INVESTIGATOR

Aurora Sinai Medical Center, Milwaukee, WI

John Gurley, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky, Lexington, KY

Barry Cabuay, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute, Minneapolis, MN

Stephen Winters, MD

Role: PRINCIPAL_INVESTIGATOR

Morristown Memorial Hospital, Morristown, NJ

Wilson Tang, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic Foundation, Cleveland, OH

Kimberly Parks, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

David Delurgio, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital, Atlanta, GA

Niraj Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Hospital, Atlanta, GA

Frank McGrew, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Memorial Hospital, Memphis, TN

Thomas O'Brien, MD

Role: PRINCIPAL_INVESTIGATOR

The Lindner Center, Cincinnati, OH

Peter Fattal, MD

Role: PRINCIPAL_INVESTIGATOR

MidMichigan Physicians Group, Midland, MI

Aaron Berman, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital, Royal Oak, MI

John Herre, MD

Role: PRINCIPAL_INVESTIGATOR

Sentara Norfolk General Hospital, Norfolk, VA

James Maher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine & Dentistry of New Jersey, Newark, NJ

Michael Craig, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Robert Gordon, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Memorial Hospital, Chicago, IL

Daniel J Lenihan, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Hospital, Nashville, TN

Thomas J. Heywood, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Green Hospital, La Jolla, CA

Rohit Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

Sanger Clinic, Charlotte, NC

Daniel Landa, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Hospital, Fullerton, CA

Anju Nohria, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital, Boston, MA

Mark Everley, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital, Kansas City, MO

Richard Troughton, MD

Role: PRINCIPAL_INVESTIGATOR

Christchurch Hospital, Christchurch, New Zealand

George Sokos, MD

Role: PRINCIPAL_INVESTIGATOR

Allegheny Singer Research Institute, Pittsburgh, PA

Paul Coffeen, MD

Role: PRINCIPAL_INVESTIGATOR

Austin Heart, Austin, TX

Ashish Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Consultants Ltd, Phoenix, AZ

Lawrence Czer, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center, Los Angeles, CA

Joseph Rogers, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Durham, NC

Tarek Nossuli, MD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital, Lancaster, PA

Dusan Kocovic, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health Center/Lankenau Hospital, Wynnewood, PA

John Boehmer, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Milton S. Hershey Medical Center, Hershey, PA

Jason Zagrodzky, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia, Austin, TX

Jerry Estep, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital, Houston, TX

Mauricio Hong, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center Cleveland, Cleveland, OH

Michael Pham, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Medical Center, Palo Alto, CA

Alaa Shalaby, MD

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System, Pittsburgh, PA

Zi-Juan Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Sutter Memorial Hospital, Sacramento, CA

Liviu Klein, MD

Role: PRINCIPAL_INVESTIGATOR

University of California at San Francisco

Jerry John, MD

Role: PRINCIPAL_INVESTIGATOR

McKay-Dee Heart Services, Ogden, UT

Pranav Loyalka, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Hermann Hospital, Houston, TX

Greg Ewald, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Debbie A. Rinde-Hoffman, MD

Role: PRINCIPAL_INVESTIGATOR

Tampa General Hospital, Tampa, FL

Frank Smart, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center, New Orleans, LA

Kelly McCants, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish Hospital, Louisville, KY

Jacob Abraham, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Heart and Vascular Institute, Portland, OR

Locations

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

Radiant Research

Santa Rosa, California, United States

Shands Jacksonville

Jacksonville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

The Emory Clinic - Crawford Long Hospital

Atlanta, Georgia, United States

St. Joseph's Hospital

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Advocate Health and Hospitals Corporation

Oakbrook Terrace, Illinois, United States

Iowa Heart Center

Des Moines, Iowa, United States

Mid-America Cardiology Associates, PC

Kansas City, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Jewish Hospital

Louisville, Kentucky, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Massachusettts Medical Center

Worcester, Massachusetts, United States

Trinity Health - Michigan d/b/a Michigan Heart

Ann Arbor, Michigan, United States

MidMichigan Physicians Group

Midland, Michigan, United States

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Bryan LGH Heart Institute

Lincoln, Nebraska, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

University of Medicine & Dentistry of New Jersey

Newark, New Jersey, United States

University of Rochester

Rochester, New York, United States

Sanger Clinic

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Northeast Ohio Cardiovascular

Akron, Ohio, 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

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Providence Heart and Vascular Institute

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Lancaster Heart Foundation

Lancaster, Pennsylvania, United States

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Main Line Health Heart Center: Lankenau Hospitals

Wynnewood, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

Austin Heart

Austin, Texas, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

Methodist Hospital Research Institute

Houston, Texas, United States

Texas Heart Institute

Houston, Texas, United States

Intermountain Heart Rhythm Specialists

Murray, Utah, United States

McKay-Dee Heart Services

Ogden, Utah, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Sentara Hospitals and Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Christchurch Hospital

Christchurch, , New Zealand

Countries

United States; New Zealand

Other Identifiers

G090084

Identifier Type: -

Identifier Source: org_study_id