LAPTOP-HF: Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT01121107

Collaborator

(none)

486

Enrollment

Locations

Arms

Duration (Months)

7.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Left Atrial Pressure Monitoring System Device: Patient Advisory Module	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

486 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Left Atrial Pressure Monitoring System Left Atrial Pressure (LAP) Monitoring System	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
Active Comparator: Patient Advisor Module Patient Advisory Module	Device: Patient Advisory Module Handheld device that provides medication reminders

Arm

Intervention/Treatment

Experimental: Left Atrial Pressure Monitoring System

Left Atrial Pressure (LAP) Monitoring System

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

Active Comparator: Patient Advisor Module

Patient Advisory Module

Device: Patient Advisory Module

Handheld device that provides medication reminders

Outcome Measures

Primary Outcome Measures

Freedom from study-related major adverse cardiovascular and neurological events (MACNE) [12 months]
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 [event driven]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Consultants Ltd	Phoenix	Arizona	United States	85032
2	St. Jude Hospital	Fullerton	California	United States	92629
3	Glendale Memorial Hospital and Medical Center	Glendale	California	United States	91204
4	Scripps Green Hospital	La Jolla	California	United States	92037
5	USC University Hospital	Los Angeles	California	United States	90033
6	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
7	VA Palo Alto Medical Center	Palo Alto	California	United States	95054
8	Sutter Memorial Hospital	Sacramento	California	United States	95819
9	University of California at San Francisco	San Francisco	California	United States	94143
10	Pacific Heart Institute	Santa Monica	California	United States	90404
11	Radiant Research	Santa Rosa	California	United States	95054
12	Shands Jacksonville	Jacksonville	Florida	United States	32209
13	Tampa General Hospital	Tampa	Florida	United States	33606
14	The Emory Clinic - Crawford Long Hospital	Atlanta	Georgia	United States	30308
15	St. Joseph's Hospital	Atlanta	Georgia	United States	30324
16	Northwestern Memorial Hospital	Chicago	Illinois	United States	60565
17	Advocate Health and Hospitals Corporation	Oakbrook Terrace	Illinois	United States	60181
18	Iowa Heart Center	Des Moines	Iowa	United States	50314
19	Mid-America Cardiology Associates, PC	Kansas City	Kansas	United States	66160
20	University of Kentucky	Lexington	Kentucky	United States	40515
21	Jewish Hospital	Louisville	Kentucky	United States	40202
22	Louisiana State University Health Sciences Center	New Orleans	Louisiana	United States	70112
23	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
24	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
25	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
26	University of Massachusettts Medical Center	Worcester	Massachusetts	United States	01655
27	Trinity Health - Michigan d/b/a Michigan Heart	Ann Arbor	Michigan	United States	48104
28	MidMichigan Physicians Group	Midland	Michigan	United States	48640
29	Beaumont Hospital, Royal Oak	Royal Oak	Michigan	United States	48314
30	Minneapolis Heart Institute	Minneapolis	Minnesota	United States	55410
31	St. Luke's Hospital	Kansas City	Missouri	United States	64111
32	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
33	Bryan LGH Heart Institute	Lincoln	Nebraska	United States	68506
34	Morristown Memorial Hospital	Morristown	New Jersey	United States	07940
35	University of Medicine & Dentistry of New Jersey	Newark	New Jersey	United States	07940
36	University of Rochester	Rochester	New York	United States	14642
37	Sanger Clinic	Charlotte	North Carolina	United States	29601
38	Duke University Medical Center	Durham	North Carolina	United States	27710
39	Northeast Ohio Cardiovascular	Akron	Ohio	United States	44304
40	The Linder Center	Cincinnati	Ohio	United States	45227
41	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
42	VA Medical Center Cleveland	Cleveland	Ohio	United States	44202
43	Ohio State University	Columbus	Ohio	United States	43210
44	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma	United States	73120
45	Providence Heart and Vascular Institute	Portland	Oregon	United States	97225
46	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17603
47	Lancaster Heart Foundation	Lancaster	Pennsylvania	United States	17603
48	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania	United States	15212
49	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania	United States	15240
50	Main Line Health Heart Center: Lankenau Hospitals	Wynnewood	Pennsylvania	United States	19096
51	Medical University of South Carolina	Charleston	South Carolina	United States	29403
52	Baptist Memorial Hospital	Memphis	Tennessee	United States	38120
53	Vanderbilt Medical Center	Nashville	Tennessee	United States	37212
54	Austin Heart	Austin	Texas	United States	78703
55	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	United States	78705
56	Memorial Hermann Hospital	Houston	Texas	United States	77030
57	Methodist Hospital Research Institute	Houston	Texas	United States	77030
58	Texas Heart Institute	Houston	Texas	United States	77030
59	Intermountain Heart Rhythm Specialists	Murray	Utah	United States	80134
60	McKay-Dee Heart Services	Ogden	Utah	United States	84403
61	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908
62	Sentara Hospitals and Sentara Cardiovascular Research Institute	Norfolk	Virginia	United States	23507
63	Aurora Sinai Medical Center	Milwaukee	Wisconsin	United States	53201
64	Christchurch Hospital	Christchurch		New Zealand

Sponsors and Collaborators

Abbott Medical Devices

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 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