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Heart Diseases clinical trials

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NCT ID: NCT02839486 Completed - Clinical trials for Congenital Heart Disease

Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass

VANCOCEF
Start date: October 1, 2017
Phase:
Study type: Observational [Patient Registry]

The aim of this study will be to evaluate vancomycin and cefoxitin blood levels during elective cardiopulmonary bypass (CPB) surgery in four pre-determined pediatric strata: neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg.

NCT ID: NCT02838355 Withdrawn - Clinical trials for Cardiovascular Disease

Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients

Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to explore how the End Tidal Carbon Dioxide monitoring via nasal cannula (ETCO2-NC) device may allow for earlier detection of respiratory complications. This device will detect the amount of carbon dioxide exhaled with each breath and may better predict high levels of this than traditional monitoring. This may reduce the number and severity of respiratory issues. A convenience sample of 60 participants either scheduled for continuous flow left ventricular assist device (CF-LVAD) implant or who have been readmitted to an ICU with a CF-LVAD will be recruited and randomized to usual care or usual care plus ETCO2-NC throughout their stay in the ICU.

NCT ID: NCT02836431 Completed - Heart Disease Clinical Trials

Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children

Start date: January 2016
Phase: Phase 1
Study type: Interventional

This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.

NCT ID: NCT02832544 Completed - Clinical trials for Rheumatic Heart Disease

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority

INVICTUS-VKA
Start date: August 22, 2016
Phase: Phase 3
Study type: Interventional

This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to VKA, with testing for superiority if non-inferiority is satisfied.

NCT ID: NCT02832531 Withdrawn - Clinical trials for Rheumatic Heart Disease

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority

INVICTUS-ASA
Start date: January 2022
Phase: Phase 3
Study type: Interventional

This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.

NCT ID: NCT02825472 Recruiting - Clinical trials for Congenital Heart Disease

Exercise Training in Grown-up Congenital Heart Disease

ExTra-GUCH
Start date: February 2016
Phase: N/A
Study type: Interventional

Rationale: Regular physical activity and aerobic exercise training are related to decreased cardiovascular mortality in healthy individuals, as well as in individuals with cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on exercise training in adult patients with congenital heart disease. Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a six-month sports participation program in addition to usual care in symptomatic adult patients with congenital heart disease improves exercise capacity and quality of life, and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Study design: International, multi-centre parallel randomized controlled trial. Study population: Adult patients with congenital heart disease, who are in New York Heart Association (NYHA) class II or III. Intervention (if applicable): The intervention group receives a six-month individualized exercise training program, the control group receives usual care. Main study parameters/endpoints: The primary outcome is the change in peakVO2 between patients in the sports participation group, and the control group. Secondary outcome measures are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought.

NCT ID: NCT02825134 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis

NOTION-2
Start date: June 30, 2016
Phase: N/A
Study type: Interventional

A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis. Study hypothesis: The clinical outcome (death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure)) obtained within one year after TAVR is non-inferior to SAVR.

NCT ID: NCT02824705 Completed - Congenital Disease Clinical Trials

Kids Intestinal Dysfunction in Congenital Heart Disease: the Kind Heart Study

Start date: April 2016
Phase:
Study type: Observational

Approximately 40,000 infants are born each year in the United States with congenital heart defects (CHD), and heart defects are the leading cause of birth defect-related deaths in the United States. While advances in surgical treatment, cardiac bypass, and post-operative management have improved mortality for children born with heart defects, these children continue to have significant morbidity related to post-operative malnutrition, multiple organ dysfunction (MODS), and sepsis. Proposed mechanisms for post-operative sepsis and MODS is via loss of intestinal epithelial barrier function (EBF) or intestinal micro biome diversity. The purpose of this multi-center observational cohort study is to understand the extent to which practice variation for routine post-operative care might worsen intestinal barrier dysfunction and reduce diversity of the intestinal microbiome for infants undergoing surgical correction of left sided cardiac obstructive defects. We will enroll 80 children with left sided obstructive congenital cardiac lesions across several US congenital cardiac centers to obtain clinical data and biological specimens. We will leverage existing differences in nutritional and antibiotic strategies at these centers to better understand how intestinal barrier function and the intestinal microbiome may contribute to post-operative multiple organ dysfunction syndrome.

NCT ID: NCT02824120 Recruiting - Clinical trials for Ischemic Heart Disease

Effects of Laugh Therapy Associated to Cardiopulmonary Rehab

Start date: June 2013
Phase: N/A
Study type: Interventional

Laugh is more than visual and vocal behave, is always followed by a series of physiological changes, including contractions of musculoskeletal system, increase of cardiac frequency by catecholamine release and hyperventilation that promoves the increase of maximum breathing and oxygen saturation. Laugh therapy may be an alternative therapy, simple, and improve the quality of life of individuals can influence physiological and biochemical parameters of the human body.

NCT ID: NCT02820727 Completed - Heart Diseases Clinical Trials

Perioperative Three Dimensional Right Ventricular Function

Start date: October 2015
Phase:
Study type: Observational

This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied.