This study is enrolling subjects who are scheduled for a ventricular tachycardia (VT) ablation. Ventricular tachycardia is a fast heartbeat that starts with an abnormal signal in the lower chambers of the heart, which are the ventricles. An ablation is a procedure where a catheter (thin, flexible tube) with a tip that can deliver energy is used to burn the heart tissue where those abnormal signals are coming from. The catheter being used in this study is called the FlexAbilityTM Ablation Catheter and was recently approved for commercial use by the Food and Drug Administration. (FDA) Since it is newly approved, the FDA wants to continue collecting more information about the catheter and its use, so this study is called a post approval study. Participation in this study will take about 1 year. During this year, data will be collected including your medical history, cardiac medication use, ablation procedure, and any medical events that may occur. You will be seen or contacted 4 times. There is a risk of loss of confidentiality and there may be risks that are not yet known. There may be no direct benefit to you but it is hoped the information learned may contribute to knowledge in this field.
This study is comparing an investigational medication called asundexian (BAY 2433334) to the medication Eliquis for the prevention of stroke or blood clots in those with atrial fibrillation (AF). Atrial fibrillation is a condition in which the upper chambers of the heart beat irregularly, and AF increases the risk of stroke. Investigational means it is not yet approved for use by the US Food and Drug Administration (FDA). This is a randomized study which means participants are assigned by chance like the flip of a coin, to either asundexian or Eliquis. The medication will be taken by mouth daily. Participants will not know which medication they are assigned to. This study will last about 3 years and involve up to 13 clinic visits. Study related procedures include collecting medical history and medications, blood work, questionnaires, electrocardiogram (ECG) - a tracing of the heart's electrical activity, and collecting information about any side effects. Study medication related risks include bleeding, bruising, feeling sick, dry mouth, diarrhea and feeling dizzy.
This study will investigate the relationships among social determinants of health (SDOH), perceived stress, coping, and quality of life (QoL) in parents of children with congenital heart disease (CHD). Surveys will be administered to assess perceived stress, coping strategies, QoL, and SDOH. Semi-structured interviews with parents of children with CHD will explore parent experiences with CHD-related stressors, current use of coping strategies, SDOH barriers and facilitators to effective coping, and preferences for future interventions to reduce stress and facilitate coping.
This will be a 26-week, prospective, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study of udenafil 87.5 mg tablets versus placebo (both taken twice daily in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption [VO2] (mL/kg/min).
This study is enrolling participants with elevated lipoprotein (a) levels, a cholesterol like substance, to test an investigational study medication called olpasiran. Investigational means it has not yet been approved by the US Food and Drug Administration (FDA) for commercial use but has been approved for use in this study. Olpasiran is a subcutaneous injection given every 12 weeks. This study is randomized, which means participants are randomly assigned, like the flip of a coin, to either receive olpasiran or placebo. Placebo looks like the study medication but has no active ingredients. Neither the participants nor the study doctor or study team will know if you are getting study medication or placebo. Participation in this study will last up to 4 1/2 years and include about 14-24 study visits. Study procedures include physical exams, medical history and medication review, electrocardiograms (tracing of the electrical activity of your heart), blood work, questionnaires and medication administration.
This clinical research study is enrolling adults who have high triglycerides (fats in the blood). The study drug, olezarsen, is an investigational drug designed to reduce triglyceride blood levels. If you meet the requirements to participate in this study, you will be randomly assigned to receive either olezarsen or placebo (an inactive substance that contains no drug). During the treatment period, participants will be asked to complete visits every 4 weeks to include a total of 19 visits over approximately 16 months. If eligible, study medication and study visits will be provided free of charge. Compensation is available.
This clinical research study is enrolling adults who have high triglycerides (fats in the blood). The study drug, olezarsen, is an investigational drug designed to reduce triglyceride blood levels. If you meet the requirements to participate in this study, you will be randomly assigned to receive either olezarsen or placebo (an inactive substance that contains no drug). During the treatment period, participants will be asked to complete visits every 4 weeks to include a total of 21 visits over approximately 16 months. If eligible, study medication and study visits will be provided free of charge. Compensation is available.