Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

NCT01121107 | Completed DMC

• 1 other identifier: G090084
• Study Type: interventional
• Target: 486
• Locations: 2 countries
• Sites: 64

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).

Conditions

Heart Failure

Keywords

Heart Failure; Decompensated Heart Failure; Acute Decompensated Heart Failure; Hemodynamic Monitoring; Implantable Pressure Monitor; Left Atrial Pressure Monitoring

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Left Atrial Pressure Monitoring System

EXPERIMENTAL

Left Atrial Pressure (LAP) Monitoring System

Device: Left Atrial Pressure Monitoring System; Device: Patient Advisory Module

Patient Advisor Module

ACTIVE COMPARATOR

Patient Advisory Module

Device: Patient Advisory Module

Interventions

Left Atrial Pressure Monitoring System DEVICE

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

Left Atrial Pressure Monitoring System

Patient Advisory Module DEVICE

Handheld device that provides medication reminders

Left Atrial Pressure Monitoring System; Patient Advisor Module

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (64)

Cardiovascular Consultants Ltd

Phoenix, Arizona, 85032, United States

Location

St. Jude Hospital

Fullerton, California, 92629, United States

Location

Glendale Memorial Hospital and Medical Center

Glendale, California, 91204, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

VA Palo Alto Medical Center

Palo Alto, California, 95054, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95819, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Radiant Research

Santa Rosa, California, 95054, United States

Location

Shands Jacksonville

Jacksonville, Florida, 32209, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

The Emory Clinic - Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

St. Joseph's Hospital

Atlanta, Georgia, 30324, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60565, United States

Location

Advocate Health and Hospitals Corporation

Oakbrook Terrace, Illinois, 60181, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

Mid-America Cardiology Associates, PC

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40515, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Massachusettts Medical Center

Worcester, Massachusetts, 01655, United States

Location

Trinity Health - Michigan d/b/a Michigan Heart

Ann Arbor, Michigan, 48104, United States

Location

MidMichigan Physicians Group

Midland, Michigan, 48640, United States

Location

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48314, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55410, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Bryan LGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07940, United States

Location

University of Medicine & Dentistry of New Jersey

Newark, New Jersey, 07940, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Sanger Clinic

Charlotte, North Carolina, 29601, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Northeast Ohio Cardiovascular

Akron, Ohio, 44304, United States

Location

The Linder Center

Cincinnati, Ohio, 45227, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

VA Medical Center Cleveland

Cleveland, Ohio, 44202, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97225, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17603, United States

Location

Lancaster Heart Foundation

Lancaster, Pennsylvania, 17603, United States

Location

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Main Line Health Heart Center: Lankenau Hospitals

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37212, United States

Location

Austin Heart

Austin, Texas, 78703, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Intermountain Heart Rhythm Specialists

Murray, Utah, 80134, United States

Location

McKay-Dee Heart Services

Ogden, Utah, 84403, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Sentara Hospitals and Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53201, United States

Location

Christchurch Hospital

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Leway Chen, M.D.

  University of Rochester, Strong Memorial Hospital, Rochester, NY

  PRINCIPAL INVESTIGATOR

• Leslie Saxon, M.D.

  USC University Hospital, Los Angeles, CA

  PRINCIPAL INVESTIGATOR

• John P. McKenzie III, MD

  Glendale Memorial Hospital and Medical Center, Glendale, CA

  PRINCIPAL INVESTIGATOR

• Steven Bailin, MD

  Iowa Heart Center, Des Moines, IA

  PRINCIPAL INVESTIGATOR

• Dhanunjaya Lakkireddy, MD

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

  PRINCIPAL INVESTIGATOR

• Hamang Patel, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

• Ayesha Hasan, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Philip B. Adamson, MD

  Oklahoma Cardiovascular Research Group, Oklahoma City, OK

  PRINCIPAL INVESTIGATOR

• Steve Hsu, MD

  Shands Jacksonville, Jacksonville, FL

  PRINCIPAL INVESTIGATOR

• John Ferguson, MD

  University of Virginia Medical Center, Charlottesville, VA

  PRINCIPAL INVESTIGATOR

• Steven Krueger, MD

  Bryan LGH Heart Institute, Lincoln, NE

  PRINCIPAL INVESTIGATOR

• Andrew Civitello, MD

  Texas Heart Institute, Houston, TX

  PRINCIPAL INVESTIGATOR

• Theo Meyer, MD

  University of Massachusetts Medical Center, Worcester, MA

  PRINCIPAL INVESTIGATOR

• Stephen W Halpern, MD

  Radiant Research, Santa Rosa, CA

  PRINCIPAL INVESTIGATOR

• Rami Alharethi, MD

  Intermountain Heart Rhythm Specialists, Murray, UT

  PRINCIPAL INVESTIGATOR

• Otfried Neidermaier, MD

  Northeast Ohio Cardiovascular Specialists, Akron, OH

  PRINCIPAL INVESTIGATOR

• Marlo Leonen, MD

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

  PRINCIPAL INVESTIGATOR

• Peter Pak, MD

  Pacific Heart Institute, Santa Monica, CA

  PRINCIPAL INVESTIGATOR

• Maria Rosa Costanzo, MD

  Advocate Health and Hospitals Corporation, Oakbrook Terrace, IL

  PRINCIPAL INVESTIGATOR

• Nasir Sulemanjee, MD

  Aurora Sinai Medical Center, Milwaukee, WI

  PRINCIPAL INVESTIGATOR

• John Gurley, MD

  University of Kentucky, Lexington, KY

  PRINCIPAL INVESTIGATOR

• Barry Cabuay, MD

  Minneapolis Heart Institute, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

• Stephen Winters, MD

  Morristown Memorial Hospital, Morristown, NJ

  PRINCIPAL INVESTIGATOR

• Wilson Tang, MD

  The Cleveland Clinic Foundation, Cleveland, OH

  PRINCIPAL INVESTIGATOR

• Kimberly Parks, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• David Delurgio, MD

  Emory University Hospital, Atlanta, GA

  PRINCIPAL INVESTIGATOR

• Niraj Sharma, MD

  St. Joseph's Hospital, Atlanta, GA

  PRINCIPAL INVESTIGATOR

• Frank McGrew, MD

  Baptist Memorial Hospital, Memphis, TN

  PRINCIPAL INVESTIGATOR

• Thomas O'Brien, MD

  The Lindner Center, Cincinnati, OH

  PRINCIPAL INVESTIGATOR

• Peter Fattal, MD

  MidMichigan Physicians Group, Midland, MI

  PRINCIPAL INVESTIGATOR

• Aaron Berman, MD

  Beaumont Hospital, Royal Oak, MI

  PRINCIPAL INVESTIGATOR

• John Herre, MD

  Sentara Norfolk General Hospital, Norfolk, VA

  PRINCIPAL INVESTIGATOR

• James Maher, MD

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

  PRINCIPAL INVESTIGATOR

• Michael Craig, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Robert Gordon, MD

  Northwestern Memorial Hospital, Chicago, IL

  PRINCIPAL INVESTIGATOR

• Daniel J Lenihan, MD

  Vanderbilt University Hospital, Nashville, TN

  PRINCIPAL INVESTIGATOR

• Thomas J. Heywood, MD

  Scripps Green Hospital, La Jolla, CA

  PRINCIPAL INVESTIGATOR

• Rohit Mehta, MD

  Sanger Clinic, Charlotte, NC

  PRINCIPAL INVESTIGATOR

• Daniel Landa, MD

  St. Jude Hospital, Fullerton, CA

  PRINCIPAL INVESTIGATOR

• Anju Nohria, MD

  Brigham and Women's Hospital, Boston, MA

  PRINCIPAL INVESTIGATOR

• Mark Everley, MD

  St. Luke's Hospital, Kansas City, MO

  PRINCIPAL INVESTIGATOR

• Richard Troughton, MD

  Christchurch Hospital, Christchurch, New Zealand

  PRINCIPAL INVESTIGATOR

• George Sokos, MD

  Allegheny Singer Research Institute, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

• Paul Coffeen, MD

  Austin Heart, Austin, TX

  PRINCIPAL INVESTIGATOR

• Ashish Gupta, MD

  Cardiovascular Consultants Ltd, Phoenix, AZ

  PRINCIPAL INVESTIGATOR

• Lawrence Czer, MD

  Cedars-Sinai Medical Center, Los Angeles, CA

  PRINCIPAL INVESTIGATOR

• Joseph Rogers, MD

  Duke University Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• Tarek Nossuli, MD

  Lancaster General Hospital, Lancaster, PA

  PRINCIPAL INVESTIGATOR

• Dusan Kocovic, MD

  Main Line Health Center/Lankenau Hospital, Wynnewood, PA

  PRINCIPAL INVESTIGATOR

• John Boehmer, MD

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

  PRINCIPAL INVESTIGATOR

• Jason Zagrodzky, MD

  Texas Cardiac Arrhythmia, Austin, TX

  PRINCIPAL INVESTIGATOR

• Jerry Estep, MD

  The Methodist Hospital, Houston, TX

  PRINCIPAL INVESTIGATOR

• Mauricio Hong, MD

  VA Medical Center Cleveland, Cleveland, OH

  PRINCIPAL INVESTIGATOR

• Michael Pham, MD

  VA Palo Alto Medical Center, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

• Alaa Shalaby, MD

  VA Pittsburgh Healthcare System, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

• Zi-Juan Xu, MD

  Sutter Memorial Hospital, Sacramento, CA

  PRINCIPAL INVESTIGATOR

• Liviu Klein, MD

  University of California at San Francisco

  PRINCIPAL INVESTIGATOR

• Jerry John, MD

  McKay-Dee Heart Services, Ogden, UT

  PRINCIPAL INVESTIGATOR

• Pranav Loyalka, MD

  Memorial Hermann Hospital, Houston, TX

  PRINCIPAL INVESTIGATOR

• Greg Ewald, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Debbie A. Rinde-Hoffman, MD

  Tampa General Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

• Frank Smart, MD

  Louisiana State University Health Sciences Center, New Orleans, LA

  PRINCIPAL INVESTIGATOR

• Kelly McCants, MD

  Jewish Hospital, Louisville, KY

  PRINCIPAL INVESTIGATOR

• Jacob Abraham, MD

  Providence Heart and Vascular Institute, Portland, OR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 12, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

NZ (1); US (63)