Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01121107




Registration number
NCT01121107
Ethics application status
Date submitted
5/05/2010
Date registered
12/05/2010
Date last updated
21/07/2023

Titles & IDs
Public title
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy
Scientific title
Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study
Secondary ID [1] 0 0
G090084
Universal Trial Number (UTN)
Trial acronym
LAPTOP-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Left Atrial Pressure Monitoring System
Treatment: Devices - Patient Advisory Module

Experimental: Left Atrial Pressure Monitoring System - Left Atrial Pressure (LAP) Monitoring System

Active comparator: Patient Advisor Module - Patient Advisory Module


Treatment: Devices: Left Atrial Pressure Monitoring System
Left atrial lead is placed for ambulatory monitoring of left atrial pressure

Treatment: Devices: Patient Advisory Module
Handheld device that provides medication reminders
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from study-related major adverse cardiovascular and neurological events (MACNE)
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Reduction in Relative Risk of Heart Failure Hospitalization
Timepoint [2] 0 0
event driven

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
486
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Georgia
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Illinois
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Iowa
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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New Zealand
State/province [28] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leway Chen, M.D.
Address 0 0
University of Rochester, Strong Memorial Hospital, Rochester, NY
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01121107