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Current Heart & Vascular Clinical Trials

Rex Healthcare Announces ALERTS Pivotal Study for Implantable Cardiac Monitor and Alert System

New study will evaluate safety and effectiveness of an implantable device, designed to reduce patient time to the ER and improve survival rates from heart attack in high-risk patients. 

Dr. Sameh Mobarek of Rex Heart & Vascular Specialists along with the Rex Heart & Vascular Research Department announces its participation in the ALERTS Pivotal US trial for the AngelMed Guardian implantable cardiac monitor and alert system. This device has an alarm which is designed to alert the patient of a potential impendingf heart attack. Often times a patient has atypical symptoms or initially no symptoms at all, causing the patient to have difficulty deciding whether or not a trip to the emergency room is warranted. The alarm system is set up to remove the delayed decision process, hence a more speedy trip to the emergency room where life saving evaluation and treatment can begin sooner rather than later.

The AngelMed Guardian system is designed to track significant changes in the heart's electrical signal and then alert patients to seek medical attention. The objective of the ALERTS Pivotal Study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian System.

According to the American Heart Association, one of every five deaths in the US is attributable to coronary heart disease. Furthermore, 50% of heart-attack fatalities occur within one hour of symptom onset and occur before the patient even reaches the hospital.

The AngelMed Guardian System is comprised of an internal implantable device about the size of a standard pacemaker with a lead into the heart, an external telemetry device, and a programmer that aids physicians in evaluating heart signals.

Rex Hospital is among the first medical facilities to participate in the AngelMed Guardian system trial. To participate in the ALERTS study, patients must meet various inclusion criteria. For more information on the AngelMed Guardian system or the ALERTS study protocol, contact Joyce Vito, RN/Study Lead (919-784-4031) at the Rex Heart & Vascular Research Department.

Other Studies:

SAPPHIRE Registry: "This is a registry study for patients with carotid artery blockages who are considered to be high risk surgical patients. This study is designed to assess the outcomes of stenting with distal protection (a tiny filter that captures debris that may be released during the procedure which may help reduce the chance of stroke) in the treatment of obstructive (blocked) carotid artery disease. The study involves two short neurological assessments which are conducted prior to the stent procedure, approximately 24 hours after the procedure, and again during a 30 day visit. Additionally, there is a brief patient questionnaire to be completed prior to the procedure and once more at the 30 day visit. The information that is obtained during this study may be used medically and scientifically to help others with carotid artery disease."

TRANSLATE Study: "This is a study enrolling patients who have had a heart attack, were treated with a procedure to open blocked blood flow in the heart, and were placed on clot-preventing medications. This study will collect information about symptoms that you may have related to your heart, the medicines you take and any health problems you may have had since your hospitalization or last phone interview. The information gathered from you and others involved in this study may provide the medical community with a better understanding of how treatments you take for your heart affect your life after you leave the hospital. An interviewer will call you about 6 weeks after your heart attack to ask you questions about your health. Interviewers will call you three more times at 6, 12, and 15 months after your heart attack. The interviews will last approximately 20 minutes."

OPEN Study: This study is for patients with moderate to severe blockages in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) in the leg. This study is designed to determine the safety and effectiveness of the FlexStent Femoropopliteal Self-Expanding Stent System and may reduce critical limb ischemia and major limb amputation. The study involves a 3 year follow-up that includes physical exam, x-ray, ultrasound, and quality of life questionnaires.

MOMENTUM Study: This study is for patients with moderate to severe blockages in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) in the leg. This study is designed to determine the safety and effectiveness of the Absolute Pro Peripheral Self-Expanding Stent System and may reduce critical limb ischemia and major limb amputation. The study involves a 3 year follow-up that includes physical exam, x-ray, ultrasound, and quality of life questionnaires.

ISIS/ICD Study: The purpose of this study is to evaluate the frequency of inappropriate ICD shocks. The ISIS- ICD study has been designed to confirm that, with the PARAD+ algorithm, it is possible to increase the percentage of patients free from inappropriate shocks in a general population implanted with a dual or triple chamber ICD device during a one year follow-up.

CANOPY Study: The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of carotid stenting experience.

For more information about heart and vascular clinical trials, contact Rebecca Palermo at (919) 784-3795 or Rebecca.palermo@rexhealth.com