The primary objective of the TRAC-AF Registry is to capture real-world safety and effectiveness data on AtriCure devices used to conduct open concomitant and/or hybrid ablation, and management of the LAA concomitant to a cardiac ablation.
Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.
Stroke· Population Health Research Institute· Houston, Texas
This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure.
Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute are eligible to participate.
This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with atrial fibrillation (AF). This study includes Screening Visit, Randomization Visit, a Treatment Period with scheduled Follow-up Visits (Monthly Follow-up and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow up Visit.
Each patient will be randomized 1:1 to receive placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR with an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose of the same study drug 10 minutes after the first dose if the patient continues to experience symptoms. Patients may treat up to a maximum of 4 episodes in the study.
Informed consent will be obtained prior to any study procedures.
Atrial Fibrillation· Milestone Pharmaceuticals Inc.· Haddon Heights, New Jersey · Manhattan, New York
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation
Atrial Fibrillation· Novartis Pharmaceuticals· Tupelo, Mississippi · Camden, New Jersey +4 more
In this pilot and feasibility study, the investigators will enroll patients with frequent symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide preliminary data for a larger study in which the investigators will test the hypothesis that a common AF genetic risk allele modulates response to different AADs.
Atrial Fibrillation· University of Illinois at Chicago· Chicago, Illinois · Oak Lawn, Illinois· Ages 18–100
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 cardiac arterial bypass grafting (CABG) or valve surgery.
Atrial Fibrillation· University of Chicago· Chicago, Illinois· Ages 20–85
The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm (rECHOmmend and ECG-AF) can identify undiagnosed cardiovascular disease in patients. It will also examine the safety and effectiveness of using this AI-based tool in a clinical setting. The main questions it aims to answer are:
1. Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease?
2. How does the use of this algorithm affect clinical decision-making and patient outcomes?
Researchers will compare the outcomes of healthcare providers who receive the AI-based ECG results to those who do not. Participants (healthcare providers) will:
Be randomized into two groups: one that receives AI-based ECG results and one that does not.
In the intervention group, receive an assessment of their patient's risk of atrial fibrillation or structural heart disease with each ordered ECG.
Decide whether to perform further clinical evaluation based on the AI-generated risk assessment as part of routine clinical care.
The purpose of the PAUSE-Virtual Study is to show that by changing pre-surgery visits with patients taking a blood thinner (direct oral anticoagulant (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) when the participant requires elective surgery, using a standard, in-person proven approach, to a virtual visit, either telephone or video conference, is as safe. Patients who are receiving a blood thinner for the medical condition known as atrial fibrillation (AF) and require an elective surgery/procedure, is common. These patients have to stop taking their blood thinner for a certain time before the procedure to reduce serious complications of stroke or bleeding. For doctors who help manage these patients before a procedure, appointments have been traditionally done in-person. Patients receive instructions about when to stop and restart their blood thinners and taught how to self-administrator a short acting blood thinner (heparin) if needed. The COVID pandemic changed the way these appointments were done, making it important to contact these patients without them having to come to the hospital for an in person visit. Virtual patient care, by telephone or video conference, to communicate to patients about when to start and restart their blood thinner was necessary. This study wants to show that this virtual method of instruction, using a standardized plan of managing patient care, is easy, acceptable to patients and as safe when compared to an in-person meeting. Such instruction would also be cost-efficient standard post-pandemic. Prior work has shown that both a standard care of patients who are receiving blood thinners and a point-of-care decision "app", available through Thrombosis Canada (www.thrombosiscanada.ca) website, have been trusted during this virtual visit successfully. The investigator will show, by following up at 30 days, that this standardized management plan is safe and can be done virtually, with a low risk of stroke and major bleeding.
PAUSE 2 study is a prospective, open-label, blinded-endpoint non-inferiority RCT of PAUSE vs. ASRA management in DOAC treated high risk patients with AF/VTE who need elective high bleed risk surgery/procedure and/or any procedure involving neuraxial anesthesia. The purpose of the PAUSE 2 study is to show that PAUSE management will be as safe (i.e., non-inferior) as ASRA management, with 95% of patients having low/undetectable pre-operative DOAC levels \<30 ng/mL in each group., at the time of surgery/neuraxial.
Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.
Atrial Fibrillation· Volta Medical· Evanston, Illinois · Overland Park, Kansas
The purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of AFF RVR.
Tachycardia Atrial· Wake Forest University Health Sciences· Oak Lawn, Illinois
The purpose of this research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats place patients at increased risk of developing clots in their bloodstream that could potentially lead to stroke. Normal care is designed to help prevent this from happening and to lessen or eliminate the symptoms patients may have. There are many different types of AF as well as numerous ways in which a variety of patients are treated. The investigators are interested in gathering more information to better keep track of patient treatment patterns (trends) that may differ from physician to physician, hospital to hospital, medication to medication, patient to patient and if necessary, procedure to procedure.
Atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) are very common conditions that often occur together and result in worsening symptoms and reduced quality of life (QoL). Limitations being able to participate in activities of daily living is a primary complaint for AF-HFpEF patients, yet effective strategies to address this issue remain limited. While exercise interventions targeting aerobic training (AT) are recommended for patients with AF and HFpEF, unique challenges exist in this patient population who tend to be older. Specifically, many older patients with AF and HFpEF have muscle weakness, sarcopenia and frailty, that can make aerobic-focused exercise difficult and less tolerable. This study proposes that starting with progressive resistance training (PRT) before aerobic exercise may overcome these issues by improving muscle strength, making AT more manageable, and leading to better health outcomes. The goal of this study is to assess whether a sequential exercise program, named 'PREACTIVE' improves how people feel, decrease the amount of symptoms, and their ability to participate in exercise and activities.
This study will specifically test a sequenced exercise approach of resistance training followed by aerobic exercise to improve symptoms, and quality of life in AF-HFpEF.
Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type. Patients with POAF tend to have worse acute and long-term clinical outcomes. BoxX-NoAF is a randomized trial to evaluate if prophylactic ablation and exclusion of the Left Atrial Appendage at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk.
Post Operative Atrial Fibrillation· AtriCure, Inc.· Jonesboro, Arkansas · San Diego, California +20 more
Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.
Paroxysmal Atrial Fibrillation· Heart Rhythm Clinical and Research Solutions, LLC· Philadelphia, Pennsylvania
The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.
Persistent Atrial Fibrillation· Boston Scientific Corporation· Mobile, Alabama · Jonesboro, Arkansas +30 more
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.
Subjects diagnosed with symptomatic recurrent paroxysmal or persistent atrial fibrillation after a single prior ablation procedure will be enrolled in this study. Each subject will undergo a study index redo ablation procedure using the Sphere-9 Catheter and Affera Ablation System and will be followed for 12 months. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 2 years.
Atrial Fibrillation (AF)· Medtronic Cardiac Ablation Solutions· Birmingham, Alabama · La Jolla, California +20 more