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.
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)
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There are 52 Locations for this study
Birmingham Alabama, 35294, United States
LaJolla California, 92037, United States
LA California, 90048, United States
Loma Linda California, 92354, United States
Long Beach California, 90806, United States
Modesto California, 95350, United States
New Haven Connecticut, 06510, United States
Newark Delaware, 19718, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32224, United States
Atlanta Georgia, 30308, United States
Lombard Illinois, 60148, United States
Davenport Iowa, 52803, United States
West Des Moines Iowa, 50266, United States
Boston Massachusetts, 02115, United States
Burlington Massachusetts, 01805, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Coon Rapids Minnesota, 55433, United States
Tupelo Mississippi, 38801, United States
Kansas City Missouri, 64111, United States
St. Louis Missouri, 63110, United States
Lincoln Nebraska, 68506, United States
Morristown New Jersey, 07962, United States
New York City New York, 10029, United States
Charlotte North Carolina, 28203, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27103, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73120, United States
Allentown Pennsylvania, 18103, United States
Lancaster Pennsylvania, 17603, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15212, United States
Wynnewood Pennsylvania, 19096, United States
Charleston South Carolina, 29425, United States
Spartanburg South Carolina, 29303, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37205, United States
Dallas Texas, 75226, United States
Dallas Texas, 75390, United States
Burlington Vermont, 05401, United States
Charlottesville Virginia, 22908, United States
Falls Church Virginia, 22042, United States
Norfolk Virginia, 23507, United States
Madison Wisconsin, 53792, United States
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