Heart Failure Clinical Trial

Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)

Summary

The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator (ICD). The investigational IHM has the ability to record and report the force with which the heart pumps blood (heart pressures). When combined with the ICD, the device has the additional ability to send a strong electrical impulse, or shock, to the heart when it detects dangerously fast heartbeats to return it to a normal rhythm. The IHM and IHM/ICD are implanted surgically just under the skin in the upper chest area. This study will also determine how doctors use the information related to heart pressures in the management of heart failure.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subjects with heart failure that only sometimes interferes with daily activities (New York Heart Association [NYHA] Class II (1)) or subjects with heart failure which severely limits daily activities (NYHA Class III (2)) at baseline
Subject has appropriate medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta blocker) for at least three months prior to the baseline evaluation.
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 baseline evaluation. (Stable is defined as no more than a 100% increase or a 50% decrease in dose.) If a subject is intolerant of ACE, ARB or beta blockers documented evidence must be available.
Subject has had at least one heart failure-related hospitalization or at least one heart failure-related emergency department or urgent care visit necessitating heart failure-related intravenous therapy (e.g. diuretic administration) within 12 months prior to the baseline evaluation

To be considered for Chronicle ICD: Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.

Exclusion Criteria:

Subjects with severe heart failure who should always be resting (NYHA Class IV(3)) or Stage D(4) refractory heart failure.
Subjects with severe renal dysfunction.
Subjects with severe non-cardiac condition limiting 12-month survival.

Subjects in concurrent studies that may confound the results.

(3)Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

(4)Stage D refractory heart failure: Patients who have marked symptoms at rest despite maximal medical therapy (e.g., those who are recurrently hospitalized or cannot be safely discharged from the hospital without specialized interventions)

Study is for people with:

Heart Failure

Estimated Enrollment:

442

Study ID:

NCT00354159

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There are 52 Locations for this study

See Locations Near You

University of Alabama at Birmingham (UAB)
Birmingham Alabama, 35294, United States
Scripps Green Hospital
LaJolla California, 92037, United States
Cedars-Sinai Medical Center
LA California, 90048, United States
Loma Linda University Medical Center
Loma Linda California, 92354, United States
Long Beach Memorial
Long Beach California, 90806, United States
Doctors Medical Center Modesto
Modesto California, 95350, United States
Yale University, School of Medicine
New Haven Connecticut, 06510, United States
Christiana Care Hospital
Newark Delaware, 19718, United States
University of FL Shands
Gainesville Florida, 32610, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
Crawford Long/Emory University Hospitals
Atlanta Georgia, 30308, United States
Midwest Heart Foundation
Lombard Illinois, 60148, United States
Genesis Hospital Midwest Cardiovascular Research Foundation
Davenport Iowa, 52803, United States
Iowa Heart Center
West Des Moines Iowa, 50266, United States
Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
Lahey Clinic Medical Center
Burlington Massachusetts, 01805, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
St Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Mercy Hospital Metropolitan Cardiology Consultants
Coon Rapids Minnesota, 55433, United States
North Mississippi Medical Center
Tupelo Mississippi, 38801, United States
Mid America Heart Institute/St. Lukes
Kansas City Missouri, 64111, United States
Washington University School of Medicine
St. Louis Missouri, 63110, United States
Bryan LGH Heart Institute
Lincoln Nebraska, 68506, United States
Morristown Memorial Hospital
Morristown New Jersey, 07962, United States
Mt Sinai Medical Center
New York City New York, 10029, United States
Carolinas Medical Center
Charlotte North Carolina, 28203, United States
Presbyterian Hospital Mid Carolinas Cardiology
Charlotte North Carolina, 28204, United States
Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
The Christ Hospital
Cincinnati Ohio, 45219, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio State University
Columbus Ohio, 43210, United States
University of Oklahoma
Oklahoma City Oklahoma, 73104, United States
Oklahoma Heart Hospital
Oklahoma City Oklahoma, 73120, United States
Lehigh Valley Heart Specialists
Allentown Pennsylvania, 18103, United States
Lancaster Heart & Stroke Foundation
Lancaster Pennsylvania, 17603, United States
Drexel University College of Medicine
Philadelphia Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Spartanburg Regional
Spartanburg South Carolina, 29303, United States
Baptist Hospital
Nashville Tennessee, 37203, United States
St Thomas
Nashville Tennessee, 37205, United States
Baylor Research Institute
Dallas Texas, 75226, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
Fletcher Allen Health Care
Burlington Vermont, 05401, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
University of Wisconsin Hospital & Clinics
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

442

Study ID:

NCT00354159

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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