Cardiovascular Research Unit
Clinical Trials and Registries

ELECTROPHYSIOLOGY STUDIES

ADAM
Arrhythmia Detection with Adherent Patient Monitoring (ADAM) Study

Principal Investigator
David Cesario, M.D., Ph.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this study is to evaluate the arrhythmia detection performance of the AVIVOT Mobile Patient Management System. The device system will continuously record heart rate, breathing, body fluid, posture, activity and temperature and compare these with data obtained by cardiac monitoring in the telemetry ward. The AVIVOT Mobile Patient Management System is considered an experimental device and is not yet approved by the FDA.

Enrollment Status: OPEN

EVE
Evaluating Ventricular Events with Adherent Patient Monitoring (EVE) Study

Principal Investigator
David Cesario, M.D., Ph.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this study is to evaluate the ability of the AVIVOT Mobile Patient Management System to detect arrhythmia. This device continuously records heart rate, breathing, body fluid, posture, activity and temperature and compares these with a standard electrocardiogram. The AVIVOT Mobile Patient Management System is considered an experimental device and is not yet approved by the FDA.

Enrollment Status: OPEN

MultiSENSE
Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients

Principal Investigator
Michael Cao, MD

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
Heart failure is a condition in which the heart muscle becomes weakened and cannot pump enough blood to meet the needs of the body.

As part of treatment for heart failure, a COGNIS® CRT-D (Cardiac Resynchronization Therapy- Defibrillator) may have already been implanted. The COGNIS-CRT-D has already been approved by the FDA (Food and Drug Administration).

The purpose of this study is to gather information from the currently implanted CRT-D that will be modified with investigational software. The study will use specially designed software and this software will collect and store information from the CRT-D.

Information from medical records will also be gathered to determine if there are ways to detect the presence of “silent” symptoms of heart failure with future devices and tests even before heart failure happens.

Enrollment Status: Pending IRB Approval

S-ICD
S-ICD® System Clinical Investigation

Principal Investigator
Leslie Saxon, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this study is to determine the safety and effectiveness of an experimental subcutaneous implantable cardioverter defibrillator called the S-ICD system to treat life-threatening ventricular tachyarrhythmias. The S-ICD device used in this study is experimental which means that it has not been approved by the Food and Drug Administration (FDA).

Ventricular tachyarrhythmia is a very fast and disorganized heart rhythm that reduces the ability of the heart to pump blood. When the heart beats too fast, it is unable to pump enough blood to the rest of the body. When this happens, a person may lose consciousness and/or may die unless the blood supply is restored.

Ventricular tachyarrhythmia is a serious heart rhythm problem and the single most common cause of death in people with heart disease.

Current treatment for ventricular tachyarrhythmias frequently requires the implantation of a permanent implantable cardioverter defibrillator (ICD) that is surgically implanted under the skin. This is an invasive procedure requiring insertion of one or more wires (leads) directly into or on to the heart.

The S-ICD system is designed to provide the same defibrillation therapy as a conventional ICD without requiring a wire to be placed in or on your heart which may be less invasive than a standard ICD implant procedure.

Enrollment Status: OPEN

Yale ICD Sports Registry
Safety of Sports for Patients with Implantable Cardioverter-Defibrillators

Principal Investigator
Leslie Saxon, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
The purpose of this multicenter registry is to evaluate the safety of participation in sports for patients with Implantable Cardioverter-Defibrillators (ICDs).

Enrollment Status: OPEN