50 Clinical Trials for Various Conditions
The purpose of this study is to perform renal artery denervation at the same time as atrial fibrillation ablation. RA denervation may reduce blood pressure, increase the chances of a successful atrial fibrillation ablation, and decrease the number of medications required to control blood pressure.
This study is being done to establish the feasibility of performing a clinical trial using a mHealth application named YouControl-AFib designed to improve the cardiovascular health of persons with atrial fibrillation. The study will obtain feedback on the app design to inform future versions and will collect preliminary data to support proof-of-concept and potential effect sizes for future trial design.
The purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing isolated cardiac arterial bypass grafting (CABG) or valve surgery.
This study aims to evaluate the safety and effectiveness of the Omron blood pressure (BP) monitor with AFib screening feature. The primary outcome is to validate if the Omron BP-monitor with AFib screening feature meets acceptance criteria in sensitivity and specificity. The acceptance criteria of the sensitivity and specificity should be statistically non-inferior to those of primary predicate device.
This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
DEFINE AFib is a prospective, observational, post-market clinical study administered to patients via the Medtronic Discovery app platform. This study will enroll approximately 5,000 patients in the United States who have a Reveal LINQ or LINQ II ICM (or future market-released LINQ devices) and an Apple® iPhone® with iOS version 13 or higher. Interested participants will be screened through the Medtronic Discovery app and those eligible will complete an app-based informed consent. Participants will receive health-focused and quality of life surveys at variable timepoints. DEFINE AFib will measure healthcare interactions using administered surveys to identify said interactions. The Medtronic Discovery app will provide participants with a summary of their ICM data. Participants will be followed up to 5 years or to the end of their ICM service life.
Patients undergoing cardiac surgery are at high risk of developing atrial fibrillation (AF), with estimated rates of 30-50% and occurs at approximately 2-4 days after surgery. The autonomic nervous system is known to play a key role in AF. Animal studies have indicated that duration and inducibility of AF can be decreased with intermittent vagus nerve stimulation (VNS). In humans, literature suggests that transcutaneous (tragus) VNS (tVNS) can serve as a potentially non-invasive therapy for treatment of post-operative AF (POAF) by reducing inflammation and increasing atrial refractory period. The purpose of this study is to determine the value of tVNS in reducing the burden of POAF and days of hospitalization after cardiac surgery.
Investigators developed a multidimensional protocol for the management of AF in the emergency department. Investigators aimed to assess if this new ER AF management protocol would result in better outcomes compared to routine care.
Atrial fibrillation (also known as AFib or AF) is the most common abnormal heart rhythm and results in an irregular beating of the heart. Currently, there is no way of identifying patients at most risk for the development or progression of AFib or those that will best respond to treatment. The purpose of this study is to improve our understanding of AFib and to find new ways of identifying those patients most at risk for developing AFib, have progressive AFib or be less responsive to treatment. For this reason, the investigators are studying imaging, blood, and digital markers that may contribute to AFib Subjects will receive mobile devices (uch as an AliveCor Kardia and a VivaLnk Wearable ECG patch or similar devices) for remote electrocardiographic (ECG) monitoring. Additionally, subjects will use features using a smartphone research app (on the Eureka Research Platform) to monitor other important things such as activity, sleep, heart rate and others as they are developed. All subjects will receive serial blood draws and saliva sample collections once a year. Subjects will also undergo annual imaging in the form of an echocardiogram (Echo). Evaluations will be taken at baseline and once a year for three years from the baseline visit. Additionally, electronic surveys will be administered periodically (eVisits occurring every 3-6 months) using the mobile app.
Shared Decision-Making: AFib 2gether™ is a research study that focuses on a mobile application developed by Pfizer, Inc with consultation from Dr McManus' called AFib 2gether™. Through this app, patients can determine their risk of stroke due to atrial fibrillation and prioritize questions and concerns for discussion with their cardiology provider.
A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention
The purpose of this research is to evaluate whether cryoballoon ablation vs. radiofrequency ablation guided by high-fidelity mapping (Rhythmia) is the best treatment strategy to perform repeat ablation for recurrent atrial fibrillation after previously having undergone cryoballoon ablation.
The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.
With this pilot study, we are hoping to test the feasibility of a larger study in the future and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial fibrillation after successful catheter ablation procedure among patients with atrial fibrillation and obstructive sleep apnea. The results from this study will help us refine the design for a future larger study, and will ultimately improve care of patients with obstructive sleep apnea and atrial fibrillation.
There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.
Prospective data collection of patients undergoing Atrial Fibrillation Ablation.
The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight administration.
1. To determine if catheter-based atrial fibrillation (AF) ablation is superior to Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with an impaired left ventricular function. 2. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic persistent or permanent AF and impaired LV function in terms of recurrence of AF, quality of life, 6-minute walk distance, EF and total number of hospitalizations.
The purpose of this study is to accurately determine, using an implantable rhythm monitor, the long-term incidence of new atrial fibrillation after ablation of atrial flutter in those treated with spironolactone compared with standard medical therapy.
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish further evidence for the clinical performance of AFGen1 on human participants.
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of AFGen1 on human participants.
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of the AFib-Chek device (a.k.a. Device) on human participants.
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency
Per the 2021 National Survey on Drug Use and Health administered by the U.S. Department of Health and Human Services, 85% of all American adults consume alcohol. Atrial fibrillation (AF) is the most common arrhythmia, affecting more than 10 million individuals in U.S., comprising 4.5% of the adult population. Although alcohol abstinence clearly reduces AF in heavy drinkers, observational data comparing the health effects of limited consumption versus abstention are conflicting. The Mediterranean diet is one of the few that has demonstrated clear cardiovascular benefits in a randomized study-this diet allows for the consumption of red wine (or high polyphenol/ low alcohol alcohol), generally not more than one drink in 24 hours, with meals, avoiding spirits and binge drinking. The effect of the "Mediterranean drinking pattern" on AF risk compared to alcohol abstinence remains unknown. This single center, randomized, controlled trial aims to compare the effects of a digital health intervention to encourage durable alcohol abstinence versus allowing guideline-adherent moderate alcohol consumption on AF severity. The knowledge gained from this study may be used to determine optimal thresholds for alcohol use among AF patients.
The goal of this study is to assess the short-term effects of minimal and moderate drinking on atrial fibrillation (AFib) episodes in a real-world population diagnosed with 'come-and-go'/paroxysmal AFib. The question it aims to answer is: Is there a greater occurrence of AFib episodes when participants are allowed to consume alcohol according to random assignment? Participants will: * Be given daily random assignments to avoid or not to avoid alcohol * Wear an adhesive electrocardiographic (ECG) heart monitor * Wear a wrist-worn fitness tracker * Wear an anklet transdermal alcohol monitor * Wear an adhesive glucose monitor * Complete morning and evening surveys daily Participants may be compensated up to $50 for full completion of the study. This study can be done in-person or remote.
Determine the role of vagal/median nerve stimulation using the CardiaCare RR2 home care wearable neuromodulation system on suppressing atrial arrhythmias and related symptoms in patients who have undergone AF ablation. The study population will be comprised of adults (age ≥18 yrs.) who have undergone AF ablation for paroxysmal or persistent AF. The study will assess the ability of neuromodulation, using the CardiaCare RR2 home care wearable, to suppress the following: 1. early (0-2 months) post-ablation arrhythmias that occur in the immediate post-ablation time period 2. AF/AT/AFL recurrences between months 2-6 post-ablation.This is a prospective, controlled, double-blind, randomized trial. The first 15 patients will not be randomized and will receive the active median/vagal stimulation only (open label). The Study will be conducted in up to 1 clinical site in the United States. This study will have 1:1 randomization (active median/vagal stimulation vs sham). The study has been given NSR designation from FDA--NO IDE.
The primary objective of this study is to evaluate the safety and effectiveness of Abbott's Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients who have non-valvular atrial fibrillation and who are at increased risk for stroke and systemic embolism and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation.