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60 active trials for Cardiac Disease

MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram

Clinical validation study of the MyoVista wavECG.

Start: May 2021

Comparison of Participants Who Received a CanGaroo® Envelope, Tyrx™ Envelope, or no Envelope During CIED Implantation

The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, Tyrx™ envelope, or no envelope.

Start: February 2021

Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease

This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months. The purpose of the study is to assess the safety and efficacy of recombinant human parathyroid hormone for treatment of adynamic bone disorder in patients with chronic kidney disease.

Start: May 2021

Retrospective Experience Of CIED Implantation

The objective of this study is to retrospectively gather information on patients who underwent a CIED procedure with either a CanGaroo, Tyrx envelope, or no envelope.

Start: April 2020

Temporary Epicardial Pace Wire With Integrated Sensor for Continuous Postoperative Monitoring of Myocardial Function

Transesophageal echocardiography is used to monitor cardiac wall motion at various time points during open-heart surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography. The CS1 system enables continuous, direct measurement of cardiac wall motion. This is achieved through use of temporary pacemaker wires incorporating a motion detector called an accelerometer. Use of TMEs during and after open-heart surgery is part of the normal clinical routine. Continuous monitoring of cardiac wall motion during and after surgery can quickly highlight the need for medical intervention with cardiac drugs and allow very early detection of potentially serious complications leading to abnormal cardiac wall motion. Cardiac wall motion activity registered by the CS1 system and echocardiography at specific time points during and after surgery will be analyzed to see how well they compare.

Start: July 2021

Validation of Quantitative Myocardial Tissue Characterization Through Non-gated CT

The main aim is to validate non-gated 5-min computed tomography myocardial relative enhancement (CT-MRE), which can be readily estimated via contrast-enhanced non-gated chest CT, as a tool for estimating myocardial extracellular volume (ECV) using cardiac magnetic resonance (CMR)-derived ECV as a reference standard in a consecutive series of patients scheduled for cardiac CT. A secondary explorative aim is to evaluate the presence and extent of possible myocardial alterations in those patients enrolled in the VALETUDO study who have been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Start: May 2021

Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass

Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate levels. The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery.

Start: May 2021

A Culturally-Based Palliative Care Tele-consult Program for Rural Southern Elders

Rural patients with life-limiting illness are at very high risk of not receiving appropriate care due to a lack of health professionals, long distances to treatment centers, and limited palliative care (PC) clinical expertise. Secondly, although culture strongly influences people's response to diagnosis, illness and treatment preferences, culturally-based care models are not currently available for most seriously-ill rural patients and their family caregivers. Lack of sensitivity to cultural differences may compromise PC for minority patients. The purpose of this study is to compare a culturally-based Tele-consult program to usual hospital care to determine whether a culturally-based PC Tele-consult program leads to lower symptom burden in hospitalized African American and White older adults with a life-limiting illness.

Start: August 2020

Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population

The study compares the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high risk for bleeding (HBR).

Start: September 2020

Sequelae of Sars-CoV-2 Infections

By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Severe courses of the infection not only affect the lungs, but also other organs like the heart, kidney, or liver. The lack of preexisting immunity might at least partially explain the affection of extra pulmonary organs not yet seen in infections due to other respiratory viruses. In this observational investigation the study group will follow up on patients that have been hospitalized due to a SARS-CoV-2 infection, and monitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system. Our that in some patients, organ damage will persist and require long-term medical care.

Start: May 2020

Evaluating Innovations in Transition From Pediatric to Adult Care - The Transition Navigator Trial

The Transition Navigator Trial (TNT) is a pragmatic randomized controlled trial evaluating the effectiveness of usual care plus a patient navigator service versus usual care plus newsletters and other educational materials, to improve transition outcomes among adolescents aged 16-21 who have chronic health conditions requiring transfer to adult specialty care. The study will provide urgently needed data to guide health care providers and policy makers regarding the provision of coordinated transition care. These results have the potential to: Change care delivery Improve health outcomes Improve the experiences of young adult transition to adult care

Start: February 2018

Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery

The purpose if this pilot study is to determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.

Start: April 2021

Platelet Transfusion During Neonatal Open Heart Surgery

Hypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood products after cardiac surgery. Background: What is the Problem? - Bleeding, Transfusion and Outcomes Excessive bleeding after neonatal cardiac surgery has been independently associated with increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart surgery has multiple etiologies such as immaturity of the building blocks of coagulation, effects of deep hypothermia, longer CPB times, altered flow states and dilutional state induced by being on CPB leading to low platelet count, low platelet function, low fibrinogen levels, altered fibrinogen polymerization, complement activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass in children was deemed to be the CPB circuit volume and the effect of hemodilution.4 The dilutional coagulopathy after neonatal CPB requires intense damage control resuscitation with massive transfusion of platelets, packed red blood cells (PRBC), cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates undergoing open-heart surgery there was a significant drop in platelet counts after bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this drop , the average intraoperative transfusion load in neonates undergoing cardiac surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg, cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In addition 72% of these patients were exposed to a 3-factor prothrombin complex concentrate (Bebulin®). Although this "throw the kitchen sink" approach is effective in achieving hemostasis, it comes with significant effects on post CPB hemodynamics, constantly changing hematocrit, variable blood volume with inability to achieve steady state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary hypertension. Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass has distinct advantages of reducing transfusions and improving outcomes.

Start: April 2017

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

SOCRATES is part of BSC's Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.

Start: March 2021

A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV endocardial border. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of NH002.

Start: November 2019

The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry

Prospective US registry of pregnant women with cardiac disease to address the substantial gaps in knowledge surrounding these patients, in order to improve future care.

Start: December 2020

Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)

Neurological dysfunction continues to be one of the complications of considerable concern in patients undergoing cardiac surgery. It was previously reported in the literature, that cerebral oxygen desaturation during cardiac surgery was associated with an increased incidence of cognitive impairment. This study aims to determine whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with predetermined intervention protocol to optimize cerebral oxygenation.

Start: March 2021

Comparing Modes of Telehealth Delivery: Phone vs. Video Visits (ASSIST)

Given the current public health crisis the use of telehealth consultation visits including phone-only and video visits has exponentially increased. This study will investigate if the conduct of telehealth phone only visits is non-inferior in terms of patient satisfaction/experience, adherence to post-visit recommendations such as medications, blood work and other medical testing, follow up care, when compared to the conduct of video delivered telehealth visits. Patients will be randomized to receive a routine care visit via phone only vs. video.

Start: May 2020

Intensive Cardiac Rehabilitation (ICR): Tolerability and Effectiveness

The purpose of this study is to fill in the gaps in knowledge on the tolerability and effectiveness of an outpatient, Pritikin-based Intensive Cardiac Rehabilitation (ICR) program on traditional cardiovascular risk factors, exercise performance, and patient well-being (as assessed by questionnaires), as well as to monitor subsequent clinical events. The hypothesis is that patients in the Intensive Cardiac Rehabilitation (ICR) group will have greater improvements in several cardiovascular disease risk factors than patients in the conventional Cardiac Rehabilitation (CR) group at the end of 24 sessions.

Start: January 2017

Women's Assessed Cardiovascular Evaluation With MCG

To compare the diagnostic accuracy, sensitivity and specificity of a CardioFlux magnetic field map study as a potential diagnostic, screening, or surveillance tool for patients with cardiac symptoms, illnesses, and/or risk factors.

Start: October 2020