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Heart Diseases clinical trials

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NCT ID: NCT03052530 Completed - Clinical trials for Coronary Artery Disease

Sapphire II PRO US Clinical Study

Start date: May 5, 2017
Phase: N/A
Study type: Interventional

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention. Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters 1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.

NCT ID: NCT03051061 Recruiting - Atrial Fibrillation Clinical Trials

Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation

ACHDAF
Start date: February 1, 2017
Phase:
Study type: Observational [Patient Registry]

The optimal antithrombotic treatment for Coronary Heart disease (CHD) patients combined with Atrial Fibrillation (AF) is unresolved at present. Although the European and American guidelines have given a hand for us, there is absence of real-world data on the safety and efficacy of antithrombotic therapy in Asian populations. Only a few clinical trials are available to guide difficult decision on antithrombotic therapy in patients with combined AF and CHD,the investigators highlight the need for the rapid development of clinical trials to close the large gaps in evidence. This research aims to know the real-world use of antithrombotic treatment and clinical prognosis in Coronary Heart Disease patients complicated with Atrial Fibrillation.

NCT ID: NCT03051048 Completed - Clinical trials for Coronary Heart Disease

System Delay and Clinical Outcome Among Chinese Patients With AMI Treated With Reperfusion Therapy (MOODY Study)

MOODY
Start date: January 1, 1999
Phase: N/A
Study type: Observational

Acute myocardial infarction (AMI) pose a pool clinical outcome to men and women whom treatment was delayed. However, reperfusion time was limited in previous studies. To evaluate the system delay and clinical outcomes among Chinese patients with AMI, consecutive inpatient case prospectively collected from 1999 to 2016. Basic data and innovative evidence will accelerate evidence-based clinical practice and policy making, and improve AMI patients outcomes finally.

NCT ID: NCT03050489 Completed - Clinical trials for Coronary Artery Disease

Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG

Start date: September 15, 2015
Phase:
Study type: Observational

Assessment of myocardial ischemic-reperfusion injury during off- and on- pump CABG.

NCT ID: NCT03050112 Completed - Clinical trials for Congenital Heart Disease

Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.

Start date: February 14, 2017
Phase: N/A
Study type: Interventional

Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome. There is nowadays a growing interest in the quality of life of this group of subjects. However, studies give contradictory results. This can be explained on one hand by the vast majority of pathologies within this population, and on the other hand by the absence of a cardio-specific tool for quality of life measurement. The MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life based on the exploration of three domains: physical, emotional and social. The aim of this study is: - to evaluate the quality of life of these patients, by using the MacNew questionnaire - to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up - to assess the mortality within this group of patients.

NCT ID: NCT03049709 Completed - Diabetes Mellitus Clinical Trials

Non-invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis

MEASURE-cBP2
Start date: May 1, 2015
Phase: N/A
Study type: Observational

There is growing evidence that central blood pressure is a better predictor of hypertensive end-organ damage and cardiovascular outcome than routine brachial readings. The investigators aimed to evaluate the accuracy of a novel device for the non-invasive determination of central blood pressure based on automated oscillometric radial pulse wave analysis.

NCT ID: NCT03049254 Recruiting - Clinical trials for Cardiovascular Diseases

Mayo AVC Registry and Biobank

Start date: February 9, 2018
Phase:
Study type: Observational

Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death. The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples. Objectives of the study: 1. Discover new genes or altered genes (variants) which cause AVC 2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation) 3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data. 4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies

NCT ID: NCT03048071 Completed - Clinical trials for Congenital Heart Disease

Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position

Start date: February 14, 2017
Phase: N/A
Study type: Observational

Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT by valved homografts is since then widely used.Pulmonary and aortic homografts then constituted the gold standard in conduit replacement between the right ventricle and the pulmonary artery (VD-AP). The increasing demand for homografts currently induces a shortage and unmet demands. This lack of availability, and the durability of homografts in young patients, has encouraged the search for alternative conducts.For example, in 1999, Medtronic® put a bovine jugular vein xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for RVOT reconstruction. This duct naturally has a central valve with three valvules, and there is on both sides of the valve a generous duct length allowing unique adaptation options. This conduit, however, is not perfect. Whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study is to compare operative morbidity and mortality when replacing Contegra® or homograft.

NCT ID: NCT03046264 Completed - Clinical trials for Coronary Heart Disease

Invasive Validation of Non-invasive Central Blood Pressure Measurements Using Oscillometric Pulse Wave Analysis

MEASURE-cBP1
Start date: September 1, 2013
Phase: N/A
Study type: Observational

There is growing evidence that central blood pressure is a better predictor of hypertensive end-organ damage and cardiovascular outcome than routine brachial readings. The investigators aimed to evaluate the accuracy of a novel device for the non-invasive determination of central blood pressure based on automated oscillometric radial pulse wave analysis.

NCT ID: NCT03045068 Completed - Cardiac Surgery Clinical Trials

Platelet Transfusion During Neonatal Open Heart Surgery

CPB
Start date: April 11, 2017
Phase: Phase 4
Study type: Interventional

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 1. 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 2. 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.