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Atrial Fibrillation clinical trials

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NCT ID: NCT05643573 Terminated - Atrial Fibrillation Clinical Trials

A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

OCEANIC-AF
Start date: December 5, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: - how long asundexian works well and - how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: - stroke and/or - systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health. The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months. Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected locations. The location name contains the abbreviation - DCT in such cases. During the study, the study team will: - take blood samples - do physical examinations - examine heart health using an electrocardiogram (ECG) - check vital signs such as blood pressure and heart rate - do pregnancy tests - ask the participants questions about their quality of life - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05643235 Recruiting - Atrial Fibrillation Clinical Trials

Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR). The incidence of new onset atrial fibrillation (AF) and other arrhythmia will be determined. Actions taken in response to device detected arrhythmia will be recorded.

NCT ID: NCT05641883 Not yet recruiting - Atrial Fibrillation Clinical Trials

CardiaMend and Amiodarone for the Prevention of POAF

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The principal purpose of this investigator-initiated trial is to study the use of the CardiaMend device soaked in the anti-arrhythmic drug amiodarone, and how it may decrease the development of atrial fibrillation in patients that have undergone a coronary artery bypass surgery, or isolated valve surgery.

NCT ID: NCT05638841 Recruiting - Atrial Fibrillation Clinical Trials

Prospective Cohort Study of the Risk of Recurrent Atrial Fibrillation After Radiofrequency Ablation

Start date: January 1, 2023
Phase:
Study type: Observational

In this study, the continuous inclusion of atrial fibrillation patients treated by catheter ablation in the Department of Cardiology, Peking University Third Hospital, through the collection of clinical data and outpatient follow-up, to explore the risk factors of atrial fibrillation recurrence after catheter ablation and the influencing factors of major clinical events in atrial fibrillation patients, and further guide the management mode of atrial fibrillation patients.

NCT ID: NCT05638100 Not yet recruiting - Atrial Fibrillation Clinical Trials

Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation

ESDDRECPNAF
Start date: January 1, 2023
Phase:
Study type: Observational

From January 2023 to December 2025, 300 elderly patients with nonvalvular atrial fibrillation in Drum Tower Hospital Affiliated to Medical Scholl of Nanjing University will be enrolled to compare the efficacy and safety of rivaroxaban-H, rivaroxaban-M and rivaroxaban-L dose in elderly patients after 24-month follow-up.

NCT ID: NCT05635864 Recruiting - Stroke Clinical Trials

Impact of Catheter Ablation on ABC Risk Scores

CathonABC
Start date: June 3, 2021
Phase:
Study type: Observational

The aim of this prospective, monocentric, non-randomized trial is to investigate the impact of catheter ablation of atrial tachyarrhythmias on the ABC-stroke and ABC-bleeding risk scores. Participants planned for first catheter ablation for symptomatic atrial tachyarrrhythmias (atrial fibrillation, atrial flutter) will be enrolled. Serial blood samples will be collected before and 3, 6 and 12 months after catheter ablation to calculate the ABC scores as well as the traditional bleeding and stroke risks. Following catheter ablation, continuous rhythm monitoring will be achieved using an insertable monitor or an implanted atrial lead of a cardiac implantable electronic device. Additionally, heart rate monitoring via photoplethysmography using a smartwatch and/or smartphone is performed for a period of six months. Data are analyzed for differences in ABC scores before and after ablation in relation to possible AF/AT recurrences. Furthermore, we are going to compare the sensitivity and specificity of different follow-up modalities post ablation. The monitoring via ICM (gold standard) is compared to smartwatch-based monitoring alone, versus smartphone-based monitoring alone or a combination of both for AT/AF recurrences.

NCT ID: NCT05633797 Recruiting - Atrial Fibrillation Clinical Trials

The Occurrence of Atrial Fibrillation After Totally Endoscopic Cardiac Surgery

AFMICS-II
Start date: March 22, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the occurrence of new-onset postoperative atrial fibrillation after totally endoscopic cardiac surgery.

NCT ID: NCT05633303 Recruiting - Clinical trials for Atrium; Fibrillation

Personalised Ablation Strategies in AF

PAS
Start date: October 14, 2022
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Catheter ablation is a safe treatment option in eliminating AF however, success rates still remains variable. Existing strategies do not take into account the differences in AF perpetuation mechanisms beyond the pulmonary veins (PVs) due to the underlying substrate. Here, I will investigate the differences in persistent AF mechanisms due to the underlying substrate and utilise these findings to generate AF mechanism specific ablation strategies. I have defined a new metric, rate-dependent conduction velocity (RDCV) slowing that has shown to correlate with sites of re-entry activity in AF. In this study, techniques and methods will be developed to measure RDCV slowing sites. The impact autonomic modulation has on AF mechanisms and CV dynamics will also be assessed. The hypothesis is that a combination of structural, electrical and autonomic remodelling play an important mechanistic role in persistent AF and ablation strategies adapted to target these will result in greater procedural success rate. The study findings have the potential to improve the success rate of catheter ablation in persistent AF thereby improve patient wellbeing and reduce the cost burden of AF treatment.

NCT ID: NCT05623527 Recruiting - Stroke Clinical Trials

Acute Cerebrovascular Events Secondary to Patients Receiving Cardiac Electronic Implants

SOS-CARE
Start date: November 20, 2022
Phase:
Study type: Observational

Objective: To investigate the incidence, clinical characteristics and prognosis of acute ischemic and hemorrhagic cerebrovascular disease secondary to the implantation of cardiovascular implantable electronic devices, so as to provide a basis for subsequent treatment strategies and risk factor stratification. Methods: This study intends to retrospectively collect the incidence and case characteristics of acute cerebral infarction, cerebral embolism, transient ischemic attack and cerebral hemorrhage in CIED patients admitted to the First Affiliated Hospital of Xi 'an Jiaotong University and other centers from January 2012 to September 2022. Then, the incidence of poor prognosis and related factors of patients within 3 months were followed up by telephone to provide a basis for subsequent treatment strategy and risk factor stratification.

NCT ID: NCT05618340 Active, not recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

PFA for Paroxysmal Atrial Fibrillation

Start date: September 26, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application. The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.