Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

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

Interventions

DEVICE

Left Atrial Pressure Monitoring System

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

DEVICE

Patient Advisory Module

Handheld device that provides medication reminders

Sponsors & Collaborators

• Abbott Medical Devices

  lead INDUSTRY

Principal Investigators

• Leway Chen, M.D. · University of Rochester, Strong Memorial Hospital, Rochester, NY

• Leslie Saxon, M.D. · USC University Hospital, Los Angeles, CA

• John P. McKenzie III, MD · Glendale Memorial Hospital and Medical Center, Glendale, CA

• Steven Bailin, MD · Iowa Heart Center, Des Moines, IA

• Dhanunjaya Lakkireddy, MD · Mid-America Cardiology Associates, PC, Kansas City, KS

• Hamang Patel, MD · Ochsner Health System

• Ayesha Hasan, MD · Ohio State University

• Philip B. Adamson, MD · Oklahoma Cardiovascular Research Group, Oklahoma City, OK

• Steve Hsu, MD · Shands Jacksonville, Jacksonville, FL

• John Ferguson, MD · University of Virginia Medical Center, Charlottesville, VA

• Steven Krueger, MD · Bryan LGH Heart Institute, Lincoln, NE

• Andrew Civitello, MD · Texas Heart Institute, Houston, TX

• Theo Meyer, MD · University of Massachusetts Medical Center, Worcester, MA

• Stephen W Halpern, MD · Radiant Research, Santa Rosa, CA

• Rami Alharethi, MD · Intermountain Heart Rhythm Specialists, Murray, UT

• Otfried Neidermaier, MD · Northeast Ohio Cardiovascular Specialists, Akron, OH

• Marlo Leonen, MD · Trinity Health-Michigan d/b/a Michigan Heart, Ann Arbor, MI

• Peter Pak, MD · Pacific Heart Institute, Santa Monica, CA

• Maria Rosa Costanzo, MD · Advocate Health and Hospitals Corporation, Oakbrook Terrace, IL

• Nasir Sulemanjee, MD · Aurora Sinai Medical Center, Milwaukee, WI

• John Gurley, MD · University of Kentucky, Lexington, KY

• Barry Cabuay, MD · Minneapolis Heart Institute, Minneapolis, MN

• Stephen Winters, MD · Morristown Memorial Hospital, Morristown, NJ

• Wilson Tang, MD · The Cleveland Clinic Foundation, Cleveland, OH

• Kimberly Parks, MD · Massachusetts General Hospital

• David Delurgio, MD · Emory University Hospital, Atlanta, GA

• Niraj Sharma, MD · St. Joseph's Hospital, Atlanta, GA

• Frank McGrew, MD · Baptist Memorial Hospital, Memphis, TN

• Thomas O'Brien, MD · The Lindner Center, Cincinnati, OH

• Peter Fattal, MD · MidMichigan Physicians Group, Midland, MI

• Aaron Berman, MD · Beaumont Hospital, Royal Oak, MI

• John Herre, MD · Sentara Norfolk General Hospital, Norfolk, VA

• James Maher, MD · University of Medicine & Dentistry of New Jersey, Newark, NJ

• Michael Craig, MD · Medical University of South Carolina

• Robert Gordon, MD · Northwestern Memorial Hospital, Chicago, IL

• Daniel J Lenihan, MD · Vanderbilt University Hospital, Nashville, TN

• Thomas J. Heywood, MD · Scripps Green Hospital, La Jolla, CA

• Rohit Mehta, MD · Sanger Clinic, Charlotte, NC

• Daniel Landa, MD · St. Jude Hospital, Fullerton, CA

• Anju Nohria, MD · Brigham and Women's Hospital, Boston, MA

• Mark Everley, MD · St. Luke's Hospital, Kansas City, MO

• Richard Troughton, MD · Christchurch Hospital, Christchurch, New Zealand

• George Sokos, MD · Allegheny Singer Research Institute, Pittsburgh, PA

• Paul Coffeen, MD · Austin Heart, Austin, TX

• Ashish Gupta, MD · Cardiovascular Consultants Ltd, Phoenix, AZ

• Lawrence Czer, MD · Cedars-Sinai Medical Center, Los Angeles, CA

• Joseph Rogers, MD · Duke University Medical Center, Durham, NC

• Tarek Nossuli, MD · Lancaster General Hospital, Lancaster, PA

• Dusan Kocovic, MD · Main Line Health Center/Lankenau Hospital, Wynnewood, PA

• John Boehmer, MD · Penn State Milton S. Hershey Medical Center, Hershey, PA

• Jason Zagrodzky, MD · Texas Cardiac Arrhythmia, Austin, TX

• Jerry Estep, MD · The Methodist Hospital, Houston, TX

• Mauricio Hong, MD · VA Medical Center Cleveland, Cleveland, OH

• Michael Pham, MD · VA Palo Alto Medical Center, Palo Alto, CA

• Alaa Shalaby, MD · VA Pittsburgh Healthcare System, Pittsburgh, PA

• Zi-Juan Xu, MD · Sutter Memorial Hospital, Sacramento, CA

• Liviu Klein, MD · University of California at San Francisco

• Jerry John, MD · McKay-Dee Heart Services, Ogden, UT

• Pranav Loyalka, MD · Memorial Hermann Hospital, Houston, TX

• Greg Ewald, MD · Washington University School of Medicine

• Debbie A. Rinde-Hoffman, MD · Tampa General Hospital, Tampa, FL

• Frank Smart, MD · Louisiana State University Health Sciences Center, New Orleans, LA

• Kelly McCants, MD · Jewish Hospital, Louisville, KY

• Jacob Abraham, MD · Providence Heart and Vascular Institute, Portland, OR

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-04-30

Primary Completion

2015-04-30

Completion

2015-04-30

Countries

• United States
• New Zealand

Study Locations