• Clinical Trials - Asthma

    Study Objective Contact
    Post -FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma [LCID Study Number: 2011-063] The purpose of this study is to test the effectiveness, safety and side effects of bronchial thermoplasty (which is performed with the Alair System) for patients with severe persistent asthma. Bronchial thermoplasty is a procedure that applies mild heat to the airway wall that is designed to reduce the amount of airway smooth muscle. The procedure reduces the ability of the airway walls to contract and narrow during an asthma attack. Principal Investigator(s):
    Carla R. Lamb, MD

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

    Study Coordinator(s):
    Joyce E. Pelletier.
    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.