• Trial(s) for Heart and Vascular Center

    Study Objective Contact
    A Study to Evaluate RenalGuard® System Safety & Efficacy when Compared with Standard Care in the Prevention of Contrast Induced Nephropathy in the Setting of a Catheterization Laboratory [LCID Study Number: 2016-009] The purpose of this study is to determine if a new treatment, called diuresis (increased excretion of urine) with matched hydration, using the investigational device The RenalGuard System, is a safe and potentially effective way to protect the kidneys from contrast induced nephropathy during a heart catheterization procedure. The study would like to show that induced diuresis with matched hydration using the RenalGuard System is better than the current treatment of giving IV fluids to patients during a catheterization procedure to prevent contrast induced nephropathy. Principal Investigator(s):
    Frederic S. Resnic, MD, MSc

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Judy E. Pendleton.
    Cardiovascular Inflammation Reduction Trial (CIRT): A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Trial of Weekly Low-Dose Methotrexate (LDM) in the Prevention of Recurrent Cardiovascular Events Among Stable Coronary Artery Disease Patients with Type 2 Diabetes or Metabolic Syndrome [LCID Study Number: 2013-070] Researchers are seeking to determine if methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome who have already had at least one heart attack or have major blockages in more than one coronary artery found on a heart catheterization. Principal Investigator(s):
    Timothy S. Draper, Jr., DO

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Judy E. Pendleton,
    Michele Rybicki, RN.
    CELESTIAL Post Approval Registry (Corox OTW, Endocardial, Left VEntricular STeroId, LeAd, BipoLar Post Approval Registry) [LCID Study Number: 2009-060] The purpose of this Registry study is to confirm the long term safety and effectiveness of the Corox OTW (-S) BP LV Lead, a non-investigational lead. In this Registry, data will be collected on the leads that connect the CRT system to the ventricles. These leads are legally marketed in the United States and not investigational products. The U.S. Federal Drug Administration (FDA) is requiring the company, BIOTRONIK, to collect additional long term data on these leads. The study involves collection and analysis (testing) of data at regular follow-up visits with your doctor. These follow up visits with your doctor are no different than would otherwise occur if you did not enroll in this study. Principal Investigator(s):
    Jonathan S. Silver, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    Circulating Tumor Cells in Patients with Primary Carcinoma of the Lung and Patients who are Candidates for Pulmonary Metastasectomy for Metastatic Colorectal, Breast, and Prostate Cancer [LCID Study Number: 2011-076] Why is this study being done? To determine if tumor cells can be isolated and treated from peripheral blood and blood from the part of lung that is being removed for the treatment of the tumor. Principal Investigator(s):
    Christina Williamson, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Deborah J. Gannon.
    Comparison of Physiologic Response with Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer [LCID Study Number: 2014-005] The purpose of this study is to determine which pacemaker response sensor is best (motion driven or breathing driven). The study is also investigating whether optimizing the sensor based on the individual patient will give better results in terms of increasing the patient's exercise capacity. Patients with or planning to receive a Boston Scientific pacemaker may be eligible to participate. Principal Investigator(s):
    G. Muqtada Chaudhry, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    CONVERGE: Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF [LCID Study Number: 2014-049] The objective of this study is to determine whether the Convergent procedure, a combination of ablation on the outside and inside of the heart, is superior to traditional catheter ablation (inside the heart only) for patients with persistent atrial fibrillation. Principal Investigator(s):
    Jonathan S. Silver, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    Evaluation Of The Safety And Efficacy Of The Optimizer™ System With Active Fixation Leads In Subjects With Heart Failure Resulting From Systolic Dysfunction: FIX-HF-5 [LCID Study Number: 2004-058] The purpose of the study is to determine the safety and efficacy of cardiac contractility modulation (CCM) treatment in improving symptoms relating to heart failure. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Florence M. Parrella, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    EVOLVE II : A Prospective, Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY™ Stent System) for the Treatment of Atherosclerotic Lesion(s) [LCID Study Number: 2013-006] The purpose of this study is to compare the safety and effectiveness of two drug-eluting stents in the treatment of coronary artery disease: the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY stent) and the PROMUS Element™ Plus Everolimus Eluting Platinum Chromium Coronary Stent System (PROMUS Element Plus stent). THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Sergio Waxman, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Judy E. Pendleton.
    Global Anticoagulant Registry in the FIELD Observing Treatment and Outcomes in Patients with Treated Acute Venous Thromboembolic Events in the Real World - GARFIELD-VTE [LCID Study Number: 2014-040] The purpose of this observational registry study is to learn more about immediate and long-term treatment and results in patients with blood clots to determine best practices in the future. Principal Investigator(s):
    Michael S. Levy, MD, MPH

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Judy E. Pendleton.
    Japan-USA Harmonized Assessment by randomized, multi-center study of OrbusNEich's combo StEnt (Japan-USA HARMONEE): Assessment of a Novel DES Platform for percutaneous Coronary Revascularization in patients with Ischemic Coronary Disease and NSTEMI Acute Coronary Syndrome [LCID Study Number: 2015-017] The purpose of this study is to test the effectiveness, safety and side effects of the Combo Stent, a new type of drug-eluting stent for patients with coronary artery disease. The Combo Stents being investigated in this study are made of metal and are covered with a medicine (called Sirolimus) to help reduce the chance of coronary arteries becoming narrow or blocked again and are coated with antibodies (called anti-CD34) that may help to protect against blood clots near the stent. Previous studies have shown evidence that the combination of the drug coating and the antibody coating significantly reduce the chance of the artery becoming narrowed again compared to other commercially available stents. It has also been shown to promote faster, more complete healing of the stent site and struts. Subjects in the study will be randomly assigned into 1 of 2 groups to receive either the Combo stent or a stent previously approved by the FDA and will be followed for 5 years. Principal Investigator(s):
    Sergio Waxman, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Judy E. Pendleton.
    Prospective Randomized EVAluation of the WATCHMAN LAA Closure Device In patients with Atrial Fibrilation Versus Long Term Warfarin Therapy (PREVAIL) [LCID Study Number: 2010-071] The purpose of this research study is to provide additional information on the WATCHMAN device to determine if the WATCHMAN device can be safely implanted and evaluate the effectiveness of the device compared to patients who receive the blood thinning medication called Coumadin (or warfarin). This study will determine if the WATCHMAN device is an alternative to Coumadin for patients with atrial fibrillation. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    Bruce G. Hook, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    QP ExCELs Sentus QP- Extended CRT Evaluation with Quadripolar Left Ventricular Leads [LCID Study Number: 2016-010] This study is for patients in whom it has been determined that a cardiac resynchronization therapy defibrillator (CRT-D) is necessary. These systems are made up of a device called a pulse generator and contains a computer that stores information about the patient's heartbeat. The purpose of this clinical research study is to test the safety, effectiveness and side effects of the investigational BIOTRONIK Sentus QP leads, (models Sentus OTW QP L-75, Sentus OTW QP L-85, Sentus OTW QP S-75 and Sentus OTW QP S-85) prior to FDA approval when used with the BIOTRONIK CRT-D device. There are 2 different models in 2 lengths available, and one will be implanted in subjects' hearts. Only the QP Sentus lead is considered investigational; the CRT-D system and the other leads are approved. However, this QP Sentus lead is approved for use in Europe. The QP Sentus lead may offer cardiologists more options to find a stable position of leads during placement, and also gives more options for reprogramming. Principal Investigator(s):
    G. Muqtada Chaudhry, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    Quadripolar Pacing Post Approval Study [LCID Study Number: 2012-021] The purpose of this study is to collect additional information on the safety and long term performance of the St. Jude Medical Quadripolar cardiac resynchronization therapy defibrillator (CRT-D) device system (Promote® Q/Promote® Quadra/Unify Quadra™/ Quadra Assura™ or any CRT-D device with quadripolar pacing capabilities and the Quartet™ left ventricular heart lead) to pace the left lower chamber of the heart in patients indicated for cardiac resynchronization therapy. THIS STUDY IS NO LONGER ACCEPTING NEW PATIENTS. Principal Investigator(s):
    G. Muqtada Chaudhry, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure with Challenging Volume Management [LCID Study Number: 2014-074] The purpose of this study is to test the effectiveness, safety and side effects of an investigational drug called tolvaptan for patients with Congestive Heart Failure (CHF). Tolvaptan is used to increase low levels of sodium in the blood in people who have heart failure. Principal Investigator(s):
    Richard D. Patten, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN,
    Michele Rybicki, RN.
    Ranolazine ICD Trial (RAID) Late Sodium Current Blockade in High-Risk ICD Patients [LCID Study Number: 2011-032] The purpose of the study is to see how effective and safe a drug called ranolazine is in reducing the risk of fast cardiac arrhythmias and death in people with implantable cardioverter defibrillators (ICDs). Principal Investigator(s):
    Jonathan S. Silver, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    Renal Denervation in Patients with Uncontrolled Hypertension -SYMPLICITY HTN-3 [LCID Study Number: 2011-080] The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in patients whose blood pressure is not controlled, despite treatment with multiple blood pressure medications. You are being considered for participation in this study because your blood pressure Principal Investigator(s):
    Sergio Waxman, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN,
    Judy E. Pendleton,
    Michele Rybicki, RN.
    Symplicity AF [LCID Study Number: 2015-005] The purpose of this study is to provide additional information about the safety and treatment effect when two medical devices (Arctic Front Advance Cardiac CryoAblation Catheter System and The Symplicity Renal Denervation System) are used together to treat your atrial fibrillation. The Arctic Front Advance Cardiac CryoAblation System is approved by the Food & Drug Administration (FDA) and is commercially available for the treatment of paroxysmal AF when medication is not working. It is already a commonly used ablation system in the lab at Lahey Hospital & Medical Center and has been used in hundreds of patients over the last four years since its approval. The system is not approved however for the treatment of persistent AF. The ablation procedure performed on a patient with persistent AF, as part of this study, is considered an experimental procedure. Renal nerve denervation is a minimally invasive procedure that may decrease the kidneys’ release of hormones that raise your blood pressure. It is thought that these same hormones play a role in heart rhythm disturbances such as AF and that disrupting the nerves of the kidney may decrease recurrences of AF. In this study, ablation near the nerves of the kidney (renal denervation) using heat (radiofrequency ablation) will be applied in order to disrupt the nerves in the kidney thought to cause hormone production and high blood pressure. In this study, this will be done with an experimental medical device called the Symplicity™ Renal Denervation System. The system includes the Symplicity Spyral™ catheter that is inserted into your blood vessels and the radiofrequency (RF)- Symplicity G3 generator. The Symplicity Renal Denervation System is not commercially available in the United States; it is considered an investigational device. The maker of the device, Medtronic, is sponsoring this study. Performing the renal denervation procedure with the Symplicity System is considered an experimental procedure. Principal Investigator(s):
    Jonathan S. Silver, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    The AEIOU Trial: Apixaban evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of atrial Fibrillation [LCID Study Number: 2015-067] There are two cohorts (groups) in the study. For the prospective, randomized cohort, the primary objective is to evaluate the efficacy and safety of apixaban uninterrupted therapy vs. interrupted therapy during the peri- and post-procedural period of catheter ablation. For the retrospective, warfarin cohort the primary objective is to assess the efficacy and safety of apixaban compared to the current clinical setting (use of warfarin). Principal Investigator(s):
    Bruce G. Hook, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
    The Leadless II Study: A Safety and Effectiveness Trial for a Leadless Pacemaker System [LCID Study Number: 2014-013] The purpose of this study is to evaluate the safety and effectiveness of a leadless pacemaker system in treating patients with slow heart rate or irregular heartbeats. The leadless pacemaker is implanted through a vein in the leg into the heart and is intended to help reduce certain complications associated with traditional pacemakers because it does not require a pocket under the collar bone and it does not have lead wires. This pacemaker is not approved by the Food and Drug Administration (FDA) and hence is considered investigational. Principal Investigator(s):
    Bruce G. Hook, MD

    For more information about this Research Study call 781-744-8027.

    Study Coordinator(s):
    Jean M. Byrne, RN.
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