COMPASS-HF Extension Phase

2014-08-27 03:18:48 | BioPortfolio


The purpose of the Extension Phase of the COMPASS-HF study is to continue to observe the safety of the Chronicle® Implantable Hemodynamic Monitor (IHM) system and provide study doctors continued access to the heart pressure information recorded by the Chronicle IHM which may be used to help manage heart failure. The Extension Phase of the COMPASS-HF study is limited to people who have already received the investigational system and are currently enrolled in a Chronicle IHM study.


For the purpose of the Extension Phase, the Chronicle IHM system is for continued use in patients with moderate to severe heart failure and is intended to monitor hemodynamic information, including right ventricular and pulmonary artery pressures, heart rate and activity. The COMPASS-HF Extension Phase includes the following Chronicle IHM studies:

- The Chronicle IHM Phase I/II study, which was a 148 patient technology assessment study that began enrolling patients in 1998 and completed the endpoint driven follow up period of 3 months for safety and 12 months for efficacy in 2002

- The Chronicle Offers Management to Patients with Advanced Signs & Symptoms of Heart Failure (COMPASS-HF) study, which was a 274 patient randomized study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 6 months in 2005

- The Pulmonary Arterial Hypertension Pilot (PAH Pilot) study, which was a 24 patient pilot study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 12 weeks in 2006

In all three studies, patients were implanted with a Chronicle IHM system and upon completion of the endpoint driven follow up period, entered long term follow up and have continued to be seen every six months for study visits.

As the Chronicle IHM system has not received U.S. Food and Drug Administration approval, the COMPASS-HF Extension Phase is being initiated as a means to allow continued access of Chronicle IHM data to study investigators in one concurrently enrolled study and follow up schedule. No additional study objectives or new enrollments will be captured in the COMPASS-HF Extension Phase.

Study Design



Heart Failure


Chronicle Implantable Hemodynamic Monitor (IHM) System


United States


Enrolling by invitation


Medtronic Cardiac Rhythm Disease Management

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:48-0400

Clinical Trials [3150 Associated Clinical Trials listed on BioPortfolio]

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

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 ...

Registry of Patients With CardioMEMS

CardioMEMS is an implantable wireless hemodynamic monitoring system which can transmit the pulmonary artery pressure. This device is FDA approved to be used as a diagnostic tool to help ma...

Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan)

This pilot study will assess the impact of sacubitril/valsartan (trade name Entresto) on the elevated pulmonary artery pressures in patients with heart failure with reduced ejection fracti...

Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

This study will evaluate an implantable pulmonary artery pressure sensor in patients with heart failure.

Monitor Patients With Acute Heart Failure

This is a prospective, multi-center, non-randomized study to evaluate performance of an external monitor for heart failure patients

PubMed Articles [16423 Associated PubMed Articles listed on BioPortfolio]

Heart-brain interactions in patients with heart failure, including takotsubo syndrome: a need to monitor autonomic sympathetic activity: reply.

The Missing Link in the Pathophysiology of Vascular Cognitive Impairment: Design of the Heart-Brain Study.

Hemodynamic balance in the heart-brain axis is increasingly recognized as a crucial factor in maintaining functional and structural integrity of the brain and thereby cognitive functioning. Patients w...

Effectiveness of Implantation of Cardioverter-Defibrillators Therapy in Patients with Non-Ischemic Heart Failure: an Updated Systematic Review and Meta-Analysis.

Implantable cardioverter-defibrillator has become the first-line therapy for prevention of sudden cardiac death. Controversial results still exist regarding the effectiveness of implantable cardiovert...

Implantable epicardial cardioverter-defibrillator-induced localized constrictive pericarditis.

In the 1990s, epicardial implantable cardioverter-defibrillator (ICD) patches were frequently implanted to treat life-threatening ventricular arrhythmia. However, owing to the high rates of functional...

Impact of Triggering Events on Outcomes of Acute Heart Failure.

The onset of acute heart failure is known to be associated with increased physical activity and other specific behaviors that can trigger hemodynamic deterioration. This analysis aimed to describe the...

Medical and Biotech [MESH] Definitions

Implantable devices which continuously monitor the electrical activity of the heart and automatically detect and terminate ventricular tachycardia (TACHYCARDIA, VENTRICULAR) and VENTRICULAR FIBRILLATION. They consist of an impulse generator, batteries, and electrodes.

A class of drugs whose main indications are the treatment of hypertension and heart failure. They exert their hemodynamic effect mainly by inhibiting the renin-angiotensin system. They also modulate sympathetic nervous system activity and increase prostaglandin synthesis. They cause mainly vasodilation and mild natriuresis without affecting heart rate and contractility.

A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.

Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES.

Small pumps, often implantable, designed for temporarily assisting the heart, usually the left ventricle, to pump blood; they consist of a pumping chamber and a power source, which may be partially or totally external to the body and activated by electromagnetic motors; the devices are used after myocardial infarction or to wean the repaired heart from the heart-lung machine after open-heart surgery.

More From BioPortfolio on "COMPASS-HF Extension Phase"

Quick Search


Relevant Topic

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...

Searches Linking to this Trial