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Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).

This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support, and to evaluate the effectiveness of the Impella BTR™ in supporting patients to recovery or their next therapy.

The purpose of this randomized study is to evaluate the safety and effectiveness of EVAHEART 2 Implantable Left Ventricular Assist System (EVA2 LVAS) by demonstrating non-inferiority to HeartMate 3 when used for the treatment of advanced, refractory, New York Heart Association Class IV heart failure.

REACT-AF is a multicenter, prospective, randomized clinical trial comparing two treatment strategies for stroke prevention in patients with a history of paroxsymal or persistent atrial fibrillation and moderate stroke-risk.

Heart failure is a harmful disease that is associated with high avoidable moribidity that can be treated with a cardiac resynchronization therapy device (CRT-D). Previous studies have shown links between CRT-D implants and reduced rates of morbidity in patients with heart failure with left bundle branch blockages (LBBB). However, there is limited amounts of evidence for the success of heart failure patients with non-LBBB. This prospective, multi-center study is looking at heart failure patients with non-LBBB that are implanted with CRT-D. 

The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD) when compared to those receiving conventional medical therapy.

The purpose of the study is to develop risk profile for unplanned or urgent healthcare use for symptoms of Heart Failure (HF). Patients with HF are hospitalized frequently to manage increasing symptoms. It is important to identify and treat those at highest risk for readmission.

Multi-center, observational post-approval registry to compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period. The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD donor hearts.

Cardiogenic shock (CS) is a dangerous clinical condition where the heart’s ability to pump blood is so compromised that it cannot support the vital functions of the rest of the body. CS has an increased risk of death of 50-60%, and despite tremendous research effort over the last decade, survival outcomes have not changed over this period. Current treatment for CS often involves mechanical circulatory support (MCS) devices, which are mechanical pumps that help support blood flow to the body.

The main objective of this study is to prospectively evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.

This is a multicenter, prospective cohort study aimed at facilitating identification of individuals with ATTR-CA. We will identify subjects with previous LSS surgery who have evidence of TTR amyloid deposits in their spinal specimens. Those with localized TTR in their spinal tissue will be invited to an on-site visit and be evaluated for the presence of clinical manifestations of ATTR cardiac amyloidosis (ATTR-CA).

This is a pilot/feasibility study on the accuracy of HRV measured by the Apple Watch on the clinical status of patients admitted for acute heart failure decompnsation. We hypothesize that there will be a statistically significant improvement in the HRV that correlates clinically over the course of hospitalization. Meaningful findings from this study will strengthen the potential for a telemonitoring system where HRV measured remotely from home using wearable devices like Apple Watch can help physicians monitoring their health and intervene accordingly.

We are interested in the side effects of medications commonly used to treat diseases like chronic myelogenous leukemia. In particular, we are interested in the effects on blood vessel cells, white blood cells, and platelets. Our data will allow us to determine any effects that these medications have on human white blood cells and platelets.

To determine whether these contributions of the Mineralocorticoid Receptor to vascular function and disease determined in animal models are also implicated in human vessels and to address the impact of sex, age, cardiovascular risk factors, and potentially race, which cannot be completely recapitulated in vitro or in mouse models.

This is a prospective, multi-center, non-randomized, single arm, post-approval study. The main objective of this study is collection of the real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of abdominal aortic aneurysm (AAA) in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.

The TRIOMPHE study is designed to further evaluate the safety and efficacy of the NEXUS™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma.

Obesity is a chronic, debilitating, multi-factorial disease that has reached worldwide pandemic proportions. The prevalence of obesity has tripled since the 1980s in many countries of the World Health Organization (WHO) European region. The WHO estimates that by 2015, 2.3 billion people will be overweight and over 700 million will be obese.

This is a single center prospective cohort study. The cohort (interventional) patients will receive the study intervention (ABCLO). The control group retrospective patients that were previously managed at the same center, regardless of the technique or the device used to close the OA.

Gore has developed and manufactures the GORE® SYNECOR Intraperitoneal Biomaterial device (GORE® SYNECOR IP Device) to offer clinicians a mesh material intended for the repair of ventral/incisional hernias that may require the addition of a nonabsorbable reinforcing or bridging material. The primary study objective is to assess SYNECOR Biomaterial performance on incisional hernia patients over an extended amount of time through multiple methods. The secondary study objective is to conduct configuration-specific assessments to address areas of medical interest.

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in patients with traumatic injury and confirmed or suspected acute major bleeding predicted to receive a large volume blood product transfusion. Randomization will be in a 1:1 ratio (BE1116:placebo) and stratified by study site. Subjects will receive a single IV infusion of either BE1116 or placebo, in addition to the study site's standard resuscitation methods and protocol.