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This is the category page. Below are all of the research programs that are associated with it
- Abdominal Aortic Aneurysms:
ENDOVASCULAR REPAIR USING THE TALENT™ ABDOMINAL STENT GRAFT SYSTEM IN ABDOMINAL AORTIC ANEURYSMS (VITALITY)
This study is for patients diagnosed with abdominal aortic or aortoiliac aneurysm who meet criteria to use the Talent Abdominal Stent Graft System in the endovascular repair of abdominal aortic aneurysms. Participants will be followed for 5 years and will need to be followed at set time points throughout the 5 years. A physical exam and radiological assessment of the implanted graft will be done at each of the follow-up office visits.
- Aneurysms -
VASCULAR RECONSTRUCTION DEVICE (VRD)AND DELIVERY SYSTEM (DS)(Humanitarian Device)
(1_20070912_118)
HDE Device – Self-expanding stent system for use with embolic coils for treatment of wide-neck, intracranial, saccular or fusiform aneurysms. Use of the device is hoped to reduce risk of subarachnoid hemorrhage by increased ability to teat aneurysms.
- Atrial Fibrillation -
MEGELLAN: A RANDOMIZED CONTROLLED TRIAL OF RADIOFREQUENCY ABLATION FOR THE TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION USING THE BARD HIGH DENSITY MESH ABLATION SYSTEM (Protocol BEP-4408-2007)
(1_20081209_118)
This study is a prospective, randomized, controlled two-arm study. Participants will be randomized to either ablation using the HDMA Toolkit (Mesh Arm), which is the investigational arm; or to be treated with AAD (the drug Arm). The hope is that use of the HDMA Toolkit (Mesh Arm) will safely decrease the occurrence of serious atrial fibrillation (AFib) up to and more than 12 months after the procedure when compared to the “Drug Arm”.
- Atrial Fibrillation -
RELY-ABLE LONG TERM MULTI-CENTER EXTENSION OF DABIGATRAN TREATMENT IN PATIENTS WITH ATRIAL FIBRILLATION WHO COMPLETED THE RE-LY STUDY AND A CLUSTER RANDOMISED STUDY TO ASSESS THE EFFECT OF A KNOWLEDGE TRANSLATION INTERVENTION ON PATIENT OUTCOMES (Protocol #1160.718)
(1_20081110_118)
This is an extension study of dabigatran treatment, in treatment in patients who successfully completed the RE-LY study. Participants will be treated for 12-36 months with open label dabigatran instead of warfarin for atrial fibrillation stroke prophylaxis. Study visits will occur every 4-5 months.
- Atrial Fibrillation -
A PHASE 2, RANDOMIZED, PARALLEL GROUP, MULTI-CENTER, MULTI-NATIONAL STUDY FOR THE EVALUATION OF SAFETY OF FOUR FIXED DOSE REGIMENS OF DU-176b IN SUBJECTS WITH NON-VALVULAR ATRIAL FIBRILLATION (PROTOCOL #PRT018)(1_20070703_118)
Use of investigational (non-FDA approved) drugs with the use of FDA-approved drug, Warfarin. This will be a randomized double-blind DU-176b and open-label warfarin study of four fixed doses of DU=176b with warfarin serving as an active control. The investigator, study subjects and sponsor will be blinded to the dose regimen of the study drug administered, but not to the identity of the study drug versus warfarin. The length of time on this study for each participant will be about 5 months, from screening through the follow-up visit.
- Cardiac - CABG:
THE EFFECT OF ACADESINE ON CLINICALLY SIGNIFICANT ADVERSE CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN HIGH-RISK SUBJECTS UNDERGOING CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY USING CARDIOPULMONARY BYPASS: RED-CABG TRIAL (REDUCTION IN CARDIOVASCULAR EVENTS BY ACADESINE IN SUBJECTS UNDERGOING CABG)
(2_20090901_118)
Participants will receive assigned treatment starting just before induction of anesthesia and continuing until 500 mL infusion is complete in approximately 7 hours. At the end of treatment, each participant will receive a follow-up evaluation (clinic visit) 28 days following surgery and again 6 months following surgery, which will be a follow-up telephone interview. Participation in the trial will be approximately 6 months from the time the informed consent form is signed until final follow-up.
- Cardiothoracic Srugery:
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, GROUP-SEQUENTIAL STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF A SINGLE DOSE OF MERCK 0657nI STAPHYLOCOCCUS AUREUS VACCINE (V710) IN ADULT PATIENTS SCHEDULED FOR CARDIOTHORACIC SURGERY
(2_20071012_118)
Patients scheduled to undergo cardiothoracic surgery will be considered. Participants will receive a single dose of study drug, V710 which is a vaccine against Staphlococcus aureas which is an infection. Participants may be followed for up to 360 days following administration of the study drug.
- Carotid Stenting Registry:
CABANA: A CAROITID STENTING BOSTON SCIENTIFIC SURVEILLANCE PROGRAM – CAROTID WALLSTENT® MONORAIL® ENDOPROSTHESIS FILTERWIRE EZ™ EMBOLIC PROTECTION SYSTEM (Protocol CDM00002892)
(1_20090207_118)
This is a registry study for patients in whom the placement of the FilterWire EZ System is attempted for patients with carotid artery disease. Data will be collected and evaluated for enrolled and consenting participants.
- Coronary Artery Bypass Graft (CABG) Surgery -
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE CARDIOPROTECTIVE EFFECTS OF MC-1 IN PATIENTS UNDERGOING HIGH-RISK CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY, (PROTOCOL #06004) SUBSTUDY PROTOCOL: ECONOMIC OUTCOMES IN MEND-CABG II (PROTOCOL #06004)
(1_20070103_118)
This study is looking for participants who are high risk patients undergoing coronary artery bypass graft (CABG) surgery. The study will use a non-FDA approved investigational drug, MC-1. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study. This study is for treatment to reduce cardiovascular events associated with ischemic damage and/or ischemia-reperfusion injury in patients undergoing CABG surgery. Participants will be randomized to receive MC-1, 250mg/day or placebo, beginning prior to CABG surgery and continuing for 30 days after surgery. Follow-up evaluations will continue for 90 days following surgery.
- Coronary Artery Disease -
PHOSPHOLIPASE LEVELS AND SEROLOGICAL MARKERS OF ATHEROSCLEROSIS: A DOSE-RESPONSE CLINICAL PHARMACOLOGY STUDY OF A-002 IN SUBJECTS WITH STABLE CORONARY ARTERY DISEASE (PROTOCOL #AN-CVD 2221)
(1_20070303_118)
This study will use a non-FDA approved, investigational drug, Oral A-002 given in different dosages. This study is a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (DAC). Patients will be randomized to receive either placebo tablets or one of orally active doses of A-002. The duration of study drug therapy will be 8 weeks.
- Coronary Artery Disease Registry -
THE ADAPT-DES STUDY (ASSESSMENT OF DUAL ANTIPLATELET THERAPY WITH DRUG-ELUTING STENTS) (2_20071014_118)
This is a prospective, multicenter registry of at least 11,000 (and up to 15,000) consecutive patients with coronary artery disease undergoing stent assisted percutaneous coronary intervention (PCI) using DES without major procedural complications. Participants will be chosen from patients undergoing PCI. Prior to PCI, participants will receive aspirin up to 6 hours prior to the procedure and Clopidogrel pre PCI or post procedure per standard of care. Participants that go on with successful PCI with at least 1 DES implanted with no major procedural complication will then be dosed at post procedure times and levels. Participants will be followed at time of discharge from the hospital; 30 days; one year and then yearly thereafter for a two year minimum or five year maximum. Only FDA approved stents may be used in this study.
- Coronary Stent Placement -
XIENCE™ V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) USA POST-APPROVAL STUDY (Protocol #06-374)
(2_20081201_118)
This is a single-arm registry per the direction of the FDA. All patients who come to Lehigh Valley Hospital for stent placement, will be asked to participate in this study. Patients will be screened at the time of admission for stent placement. However, the patient will not know until following the stent placement whether or not they were eligible for the study based on whether or not the Xience stent system was used. Following the procedure, the patient will continue with the study or be excluded. If the patient did not receive the Xience stent system, the participant will be advised. Stent thrombosis rates will be looked at 24 hours; 30 days and once a year for five years. All cardiac deaths and MI’s will be assessed for the first five years.
- Heart Failure -
CHAMPION: CARDIOMENS HEART SENSOR ALLOWS MONITORING OF PRESSURE TO IMPROVE OUTCOMES IN NYHA CLASS III HEARAT FAILURE PATIENTS (Protocol #CM-06-04)
(1_20081015_118)
This is an Interventional, Diagnostic, Randomized, Single Blind, Placebo Controlled, Parallel Assignment, Safety/Efficacy Study. There will be two study groups. The study will last for three years or until the study is stopped. The study involves a device that will be implanted into the pulmonary artery at the time of cardiac cath. One group called the Treatment Group will receive the standard of care plus the experimental device; and the other group called the Control Group, will received standard of care only. The device is a Heart Failure Pressure Measurement System, which is a pressure sensor that will be used to monitor heart failure.
- Heart Failure -
DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER ACUTE STUDY OF CLINICAL EFFECTIVENESS OF NESIRITIDE IN SUBJECTS WITH DECOMPENSATED HEART FAILURE (PROTOCOL #A-093, JNJ-27410084)(2_20070717_118)
Use of FDA-approved drug, Nesiritide. This is a double-blind, placebo-controlled, multicenter study. This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Participants will be randomly assigned to 1 of 2 treatment groups, nesiritide or placebo. The study will be divided into a screening phase, a double-blind treatment phase and a follow-up phase including a Day-30 visit and a Day-180 telephone contact. A pharmacogenomic blood sample (10 mL) will be collected from subjects who give separate written informed consent for this component of the study. Participation in the pharmacogenomic research is not necessary to participate in this study.
- Heart Failure -
EARLY BEDSIDE ECHOCARDIOGRAPHY: IMPACT ON TIME TO DIAGNOSIS, LENGTH OF STAY, CLINICAL OUTCOMES AND COST IN PATIENTS WITH HEART FAILURE
(1_20080706_118)
All patients presenting to the ED at LVH-Cedar Crest, Monday through Friday, 8AM to 2 PM, with a chief complaint of dyspnea will be screened for enrollment. Patients in whom there is a clinical suspicion of heart failure and who meet the inclusion criteria will be asked to participate. Patients who agree to participate will be randomized to one of two groups, either the early echo group, or the standard of care group. Participants enrolled into the early echo group will receive at bedside a complete Doppler echocardiographic exam performed within 90 minutes of randomization. The standard of care group will go on to have care as determined by the attending ED doctor and admitting doctor.
- Heart Failure Patients -
WARFARIN VERSUS ASPIRIN IN REDUCED CARDIAC EJECTION FRACTION (Protocol WARCEF)
(1_20071008_118)
This is a study comparing two FDA approved drugs, Warfarin and Aspirin. This is a double-blinded randomized multicenter trial. Participants will be randomized to one of two arms. All participants will receive two medications. The first medication is either a 2 mg warfarin tablet, or an identical appearing placebo tablet. The second mediation is a 325 mg aspirin tablet, or an identical appearing placebo tablet. After the initial INR stabilization period, the patient is scheduled to visit the clinical site every month for an INR blood draw and monthly contact interview. Participants will be evaluated in the clinic every four months.
- Hospital Educational Study -
LOCATING ERRORS THROUGH NETWORKED SURVEILLANCE (LENS)
(1_20090208_118)
This study is designed to observe the standard of care for patients undergoing cardiac surgery. Allowing individuals involved in their care an opportunity to provide feedback, be observed and participate in structured interviews that may contribute to enhanced safety for this patient population.
- Myocardial Infarction -
CAROTID STENTING FOR HIGH SURGICAL-RISK PATIENTS; EVALUATING OUTCOMES THROUGH THE COLLECTION OF CLINICAL EVIDENCE (PROTOCOL #06-717)
(1_20070305_118)
This study is an Investigational Device Use for the Abbott Vascular Emboshield®, Xact® Carotid Stent System, RX ACCULINK™ Carotid Stent System and the RX ACCUNET™ Embolic Protection System. This is a prospective, non-randomized, multi-center, descriptive, post-market study of two carotid artery stent systems and two embolic protection systems. Participants will be evaluated using the NIH Stroke Scale (NIHSS) by a medical professional. These evaluations will be performed at the following time points: within 14 days prior to the stent procedure; within 24 hours post-procedure and at 30 days post-procedure. During the 24-hour post-procedure and 30-day follow-up assessments, any occurrence of death, stroke, myocardial infarction (MI), new neurologic events, and device related adverse events will be reported.
- Myocardial Infarction -
CAN SUBCLINICAL ATHEROSCLEROSIS IMAGING PREDICT THE RISK OF A FIRST S-T ELEVATION MYOCARIAL INFARCTION? A RETROSPECTIVE STUDY (Investigator Initiated Protocol)(1_20070805_118)
Study subject will be patients admitted to Lehigh Valley Hospital, Cedar Crest site, with a first ST elevation myocardial infarction (STEMI) or non-STEMI acute coronary syndrome. These patients are admitted to ACU, where the census will be assessed on a daily basis by the PI and sub-investigator.
- Stable Chronic Heart Disease -
A PHASE III, DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECTS OF RO4607381 ON CARDIOVASCULAR (CV) RISK IN STABLE CHD PATIENTS, WITH A DOCUMENTED RECENT ACUTE CORONARY SYNDROME (ACS) (Protocol #NC20971)
(2_20080617_118)
This is a double-blind, placebo-controlled, parallel group for patients recently hospitalized for Acute Coronary Syndrome (ACS). Patients will be followed during their hospital stay. Upon discharge potentially eligible patients will enter a single blinded placebo run-in period of approximately 4 to 6 weeks to allow for patient stabilization and completion of planned revascularization procedures. The run-in period may be extended. At the end of the run-in period, participants will be randomized to receive either 600 mg of study drug or placebo. Participants will be treated until 1,600 events occur but at least for a minimum of 2 years. Participants will need to visit the clinic at 4 weeks and then 3 months after randomization and every 3 months during the first year. Thereafter, visits will be every 4 months.
- Stroke -
THE “PFO ACCESS” REGISTRY STUDY: PATENT FORAMEN OVALE CLOSURE WITH THE AMPLATZER® PFO OCCLUDER IN PATIENTS WITH RECURRENT CRYPTOGENIC STROKE DUE TO PRESUMED PARADOXICAL EMBOLISM THROUGH A PATENT FORAMEN OVALE WHO HAVE FAILED CONVENTIONAL DRUG THERAPY
(1_20061204_118)
This is a device study. This device is a percutaneous transcatheter occlusion device intended for the non-surgical closure patient who has already experienced at least two cryptogenic strokes due to presumed paradoxical embolism and who has failed conventional drug therapy. Patients will be followed or one year from the date of implant or until registry closure. Once the device is approved, this registry will be closed. This device is investigational and will remain permanently in the heart.
- STUDY CLOSED TO ACCRUAL: Carotid Artery - PROTECTED CAROTID ARTERY STENTING IN SUBJECTS AT HIGH RISK FOR CAROTID ENDARTERECTOMY (CEA) (DEVICE STUDY, PROTOCOL #640-0071-01)(1_20070502_118)
Use of an investigational device, Emboshield® Pro Rapid Exchange Protection System (Generation5). This is a prospective, non-randomized, multicenter, single arm trial. All participants will receive the Xact® Rapid Exchange Carotid Stent System. Of the total participants enrolled the first 220 consecutively enrolled subjects will be treated with the investigational filter system, the Emboshield® Pro Rapid Exchange Protection System (Generation 5). The remaining subjects will be treated with the FDA approved Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation3). Participants will be followed at 30 days, 12 months and annually thereafter for a total of three years.
- STUDY CLOSED TO ACCRUAL: Chronic Heart Failure - REDUCING DECOMPENSATION EVENTS UTILIZING INTRACARDIAC PRESSURES IN PATIENTS WITH CHRONIC HF (REDUCE HF/CHRONICLE ICD) CHRONICLE® IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
(1_20080105_118)
This study will use an investigational device, Medtronic Model 7286 Chronicle ICD System and has been reported to pose a significant risk. ICD stands for Implantable Cardioverter Defibrillator. Participants must have a qualifying heart failure hospitalization or heart failure emergency department visit necessitating heart failure intravenous therapy intervention. Participants will be randomized following successful implant and will remain in randomized follow up through the 12 month protocol required visits. After the 12-month protocol required visit, reduced data capture will be implemented. The subjects will have long term protocol required visits beginning at 18 months and every 6 months thereafter until market approval or study completion. This study device is intended for use in participants with NYHA Class II and Class III heart failure who are also indicated for a single chamber ICD based on the most recent guidelines from the American College of Cardiology.
- Study Closed to Accrual: Coronary Artery Disease -
A PROSPECTIVE EVALUATION IN A RANDOMIZED TRIAL OF THE SAFETY AND EFFICACY OF THE USE OF THE TAXUS® PACLITAXEL-ELUTING CORONARY STENT SYSTEM FOR THE TREATMENT OF DE NOVO CORONARY ARTERY LESIONS (PROTOCOL #S2037-PIVOT-2006)(2_20070710_118)
Use of an investigational device, TAXUS Element Stent. Participants will be identified by the Cath Lab census at Lehigh Valley Hospital. Participants will be randomized to two groups, to receive either the test device or control device. Participants will have follow-up at 30 days, 9 months, 1, 2, 3 4 and 5 years. This study will be considered complete at the time all participants have completed the 12 month follow-up.
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