This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
This study is an open label extension of the ACT-EARLY study. which included those with no evidence of ATTR but are known carriers of disease causing TTR gene. ATTR stands for transthyretin amyloidosis. It is a condition in which a protein called transthyretin (TTR) accumulates in various organs, including the heart (known as ATTR-CM), kidneys, and nerves (known as ATTR-PN). This accumulation can lead to damage and dysfunction in these organs.
This study will continue using the study drug acoramidis (AG-10) to determine if it can help people with the genetic TTR variant slow the progression of ATTR. AG-10 is an investigational drug. Investigational means that AG-10 is not yet approved for use in any settings outside of clinical research studies like this one. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time.
Participation in this study will last up to 60 month and will consist of about 13 clinic visits and about 11 telephone follow up visits. Some tests required include physical exams, medical and surgical history, bloodwork, questionnaire, electrocardiogram (test that records your heart's electrical activity), echocardiogram (ultrasound test of your heart) and study drug administration.
SV-ONE represents the integration of NPC-QIC within the existing FON framework. As such, SV-ONE will engage in research and improvement efforts through the entire lifespan of patients with SVHD, including but not limited to those with a Fontan circulation. The larger objective of this study is to increase longevity and enhance the QoL by improving physical health and functioning, mental health and resilience, and neurodevelopment for individuals with SVHD and their families. A longer-term goal of SV-ONE will be to serve as a platform for research and improvement that will
accelerate advances, with the potential to nest clinical trials and to link to registries and programs,
nationally and internationally.
The GRIT-PKP2 study will evaluate the long-term safety and tolerability of LX2020 gene therapy for subjects with PKP2-ACM who have previously received an investigational study medication called LX2020. PKP2-ACM is an inherited heart condition which can cause heart muscle and electrical damage. Investigational means it is not approved for use by the Food and Drug Administration (FDA). There is no investigational treatment being administered in this study. The overall study duration is 4 years. The study consists of 7 visits: a rollover visit, an outpatient monitoring period, (5 visits, 18 months to 48 months after LX2020 administration in Study LX2020-01), and an end-of-study visit. Procedures and activities that subjects will undergo are: quality of life questionnaires, ECG, MRI, ultrasound, ECHO, collection of samples, remote cardiac monitoring, and collection of vital signs.
The purpose of this research is to assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
This study will have a 1:1:1 randomization post the implantation of the WATCHMAN DLX Pro Device comparing three different medications used after the WATCHMAN FLX Pro Device is placed. The goal of this study is to see how safe and effective the medications are after the device is placed. The three different arms include the following: Aspirin only for 12-month study duration, reduce dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC), either commercially available apixaban (preferred) or rivaroxaban for first 3-months, followed by aspirin, or Aspirin +clopidogrel) for first 6 months followed by aspirin only.
In this study, we will look back at past medical records to test how well two computer-based tools can help spot two types of heart disease: hypertrophic cardiomyopathy (HCM) and a form of cardiac amyloidosis called transthyretin amyloidosis (ATTR). One tool analyzes heart ultrasound images (echocardiograms) using artificial intelligence to identify signs of these conditions. The other tool looks at patterns in electronic health records—like diagnoses, test results, and medications—to flag patients who may have HCM or ATTR. Our goal is to see how accurate and useful these tools are in finding patients who may need further evaluation or care.
In this study, we will look back at past medical records to test how well two computer-based tools can help spot two types of heart disease: hypertrophic cardiomyopathy (HCM) and a form of cardiac amyloidosis called transthyretin amyloidosis (ATTR). One tool analyzes heart ultrasound images (echocardiograms) using artificial intelligence to identify signs of these conditions. The other tool looks at patterns in electronic health records—like diagnoses, test results, and medications—to flag patients who may have HCM or ATTR. Our goal is to see how accurate and useful these tools are in finding patients who may need further evaluation or care.
In this study, we will look back at past medical records to test how well two computer-based tools can help spot two types of heart disease: hypertrophic cardiomyopathy (HCM) and a form of cardiac amyloidosis called transthyretin amyloidosis (ATTR). One tool analyzes heart ultrasound images (echocardiograms) using artificial intelligence to identify signs of these conditions. The other tool looks at patterns in electronic health records—like diagnoses, test results, and medications—to flag patients who may have HCM or ATTR. Our goal is to see how accurate and useful these tools are in finding patients who may need further evaluation or care.
In this study, we will look back at past medical records to test how well two computer-based tools can help spot two types of heart disease: hypertrophic cardiomyopathy (HCM) and a form of cardiac amyloidosis called transthyretin amyloidosis (ATTR). One tool analyzes heart ultrasound images (echocardiograms) using artificial intelligence to identify signs of these conditions. The other tool looks at patterns in electronic health records—like diagnoses, test results, and medications—to flag patients who may have HCM or ATTR. Our goal is to see how accurate and useful these tools are in finding patients who may need further evaluation or care.