Trial record 1 of 1 for:    NCT01121107
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Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01121107
First received: May 5, 2010
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Heart Failure
Device: HeartPOD™ System or Promote® LAP System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from study-related major adverse cardiovascular and neurological events (MACNE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 730
Study Start Date: April 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment

Patients will be receive a Left Atrial Pressure (LAP) Monitoring System in one of the following devices depending on their medical condition:

  1. Stand-alone implantable LAP monitoring device
  2. CRT-D device with an integrated LAP monitoring device
Device: HeartPOD™ System or Promote® LAP System

HeartPOD system is a standalone for use in patients not requiring ICD or CRT-D therapy or who are already receiving ICD or CRT-D therapy.

Promote LAP system is a combination device for patients who require ICD or CRT-D therapy in addition to LAP monitoring.

No Intervention: Control
Patients receive a standard of care cardiac rhythm management device and a hand held Patient Advisor Module (PAM) which provides a daily reminder of their medication schedule

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121107

  Show 64 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: 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 Medical Center, New Orleans, LA
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
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01121107     History of Changes
Other Study ID Numbers: G090084
Study First Received: May 5, 2010
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
Heart Failure
Decompensated Heart Failure
Acute Decompensated Heart Failure
Hemodynamic Monitoring
Implantable Pressure Monitor
Left Atrial Pressure Monitoring

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014