Search Tufts Medicine

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.

Open label trial of letermovir prophylaxis for those heart transplant recipients at risk of cytomegalovirus infection and disease

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.

The primary goal of this study is to improve our understanding of changes in skeletal muscle mass in the arms and the legs during a hospitalization for advanced HF. We plan to measure muscle thickness with an ultrasound machine in two locations on the body (the outer thigh and the upper arm muscle, of the dominant side) from the time a patient is first admitted to the ICU with HF as well as before and after any surgical HF therapies.

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 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.

Randomized Arm: This is a prospective, open label, randomized, controlled, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in patients enrolled with NYHA Class II Heart Failure. Single Arm:This is a prospective, open label, single arm, controlled, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in patients enrolled with NYHA Class III Heart Failure comparedto a Performance Goal (PG).

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.

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.

This is a pilot, multinational, multicenter, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of males or females 18 to 85 years of age, hospitalized for acute decompensated heart failure (ADHF) with persistent hypotension (systolic blood pressure [SBP] 70-100 mmHg for two hours) and heart rate 75 to 150 beats/minute.

This research is being done to study a potential method of improving blood flow and oxygen delivery to the organs of patients on VA-ECMO. This study involves positioning the return cannula in the aorta, which is the main artery that carries blood away from the heart. We aim to prove that returning oxygenated blood to the aorta is safe and feasible. We also aim to better understand the effects that this method may have on the forces that affect blood flow and heart function.

Collecting and storing heart tissue and blood samples from consented Tufts Medical Center patients for the purpose of cardiovascular research.

Collection of TRV and RVOT VTI from TEE and right heart pressures and CO from PA catheter.

This study explores changes in heart function before and after activation of Impella or ECMO devices used to support subjects in cardiogenic shock. 

The primary goal of this study is to use the WHOOP fitness band as a way to measure heart rate variability (HRV) in patients with coronary artery disease (CAD) and to establish a change in HRV before coronary artery bypass graft (CABG) surgery and during post-operative stay. The secondary aim of this study would be to associate this change in HRV with the patient’s clinical course. The validation component will test WHOOP’s HRV capabilities compared to the gold-standard Holter monitor. 

This is a Prospective, multi‐center, international, randomized controlled, post‐market trial.

Severe skeletal muscle loss (wasting) and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low or high dose protien supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition.

This is a Prospective, multicenter, randomized, parallel-controlled, open-label two arm trial with an adaptive design. Eligible subjects will be randomized in a 1:1 ratio to PCI with Impella CP® (Intervention Group) versus standard of care PCI with or without IABP (Control Group). Approximately 1252 subjects will be randomized in a 1:1 ratio to PCI + Impella vs. PCI ± IABP.

Patients who are admitted to the Tufts Medical Center ICU or PICU and are deemed to require placement of an intracranial pressure (ICP) monitor will be asked to enroll in our study. Patients agreeing will undergo the routine placement of an ICP monitor followed by placement of the study device; a non-invasive extracranial device (I PASS - Intracranial Pressure Assessment and Screening System, Vivonics, INC) containing near infrared probes placed on the ear, forehead and finger. The data will be recorded from IPASS as the routine ICP is recorded.

This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to background PAH therapy in newly diagnosed intermediate- and high-risk PAH patients.