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Atrial Fibrillation clinical trials

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NCT ID: NCT05509517 Completed - Atrial Fibrillation Clinical Trials

A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery

SURGICAL-AF 2
Start date: November 2, 2021
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (POAF) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge.

NCT ID: NCT05486364 Completed - Atrial Fibrillation Clinical Trials

DIGITal mOnitoring afTer Af abLation

DIGITOTAL
Start date: December 20, 2021
Phase: N/A
Study type: Interventional

Recurrence of atrial fibrillation (AF) after a pulmonary vein isolation (PVI) procedure is frequent. Current follow up with Holter monitoring and electrocardiograms (ECG) during outpatient clinic consultations cover only short time stretches and require hospital visits. Mobile health solutions with rhythm monitoring using photoplethysmography (PPG) technology on a smartphone could extend rhythm monitoring time, while lowering hospital visits and cost. This study aims to compare the performance of a digital health solution using PPG technology on a smartphone versus the current standard of care to monitor for AF recurrence after a PVI procedure.

NCT ID: NCT05475028 Completed - Atrial Fibrillation Clinical Trials

Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)

PRESMET
Start date: September 14, 2021
Phase:
Study type: Observational

Heart failure (HF) is a syndrome, resulting from structural or functional impairment of ventricular filling or ejection of blood. Effective HF management depends on accurate and rapid diagnosis requiring assessment of symptoms and physical signs in combination with advanced and expensive imaging tools. However, several challenges arise from the traditional symptom-based diagnosis because co-morbidities of HF have similar presentations. This implies the need for a deeper knowledge of mechanistic links among genetic and epigenetic events governing the pathophysiology of HF leading to a novel molecular-based system to differentiate HF phenotypes. Now, it is emerging that the pathophysiology of HFpEF and HFrEF is different, it provides an opportunity to identify biomarker candidates that could aid in HF diagnosis and stratification between these two forms of the disease. The aim of PRESMET project is to perform liquid biopsy strategies to identify novel putative non-invasive epigenetic-sensitive biomarkers that could be used either alone or in combination with established diagnostic tests, such as natriuretic peptide, to help differentiate HFpEF from HFrEF. The Investigators will perform DNA methylation analysis on CD4+ T cells isolated from patients versus controls. Remarkably, big data generated from NGS tools will be analyzed by advanced network-oriented algorithms. Our results may provide a useful clinical roadmap in order to improve precision medicine and personalized therapy of HF.

NCT ID: NCT05471830 Completed - Atrial Fibrillation Clinical Trials

An Observational Study (Called RETAF-PS) Using a Patient Survey to Learn More About Treatment Outcomes in Patients With Irregular and Often Rapid Heartbeat (Atrial Fibrillation) Treated With Apixaban in a Real World Setting

Start date: November 30, 2022
Phase:
Study type: Observational

This is an observational study in which data from people with atrial fibrillation who received or are currently receiving the drug apixaban to prevent thromboembolic events (blood clots that travel through the blood stream to plug another smaller vessel) are studied. In observational studies, only observations are made without specified advice or interventions. Atrial Fibrillation (AF) is a condition of having irregular and often rapid heartbeat. AF can lead to the formation of blood clots in the heart and to embolism, a condition that happens when a blood clot travels through the blood stream to plug another smaller vessel. This can 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 AF can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. This is a complex series of steps that must occur in a specific sequence. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs). 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. In the beginning, there was only one main class of OAC called vitamin k antagonists (VKAs) prescribed in usual practice. VKAs work by lowering the number of coagulation factors in the blood. Over the years, newer OAC medications have become available which act more specifically by interrupting one or more of the coagulation steps and preventing the blood from clotting. The study treatment apixaban works by blocking a very specific step in the blood clotting process, the activation of a protein called Factor Xa. Newer OACs are also called direct oral anticoagulants (DOACs). DOACs require less monitoring by doctors, but an increased risk of bleeding remains. Bleedings can be an important reason for stopping therapy. One type of bleeding called patient relevant bleeding (PRB) has not been intensely studied so far. PRB is a type of minor bleeding which is bothersome, but which does not require medical treatment as it has no important impact on a person's health. It needs to be distinguished from so called clinically relevant non-major bleeding (CRNMB). CRNMB stands for a type of bleeding which may have an important impact on a person's health and needs medical attention, but when treated, is not likely to have a negative impact on a person's health. Only limited information is available for PRB and CRNMB related to the treatment with DOACs in real-world settings. In this study, researchers want to collect more data about how often PRB and CRNMB occur in people with AF treated with apixaban. In addition, researchers want to learn how these medical problems affect the treatment with apixaban under real-world conditions. To do this, researchers will count the number of participants in usual practice - who have PRB or CRNMB and who are being treated with apixaban at the time of this ongoing study or who have recently taken this drug, but have switched to another OAC, - who have PRB or CRNMB and have decided to stop or to continue their treatment with apixaban. In addition, characteristics of each participant and the reason for continuation or discontinuation of apixaban will be collected and described. The data for this study will come from patient surveys. Besides this data collection, no further tests or examinations are planned in this study. The participants who take their apixaban treatment during this study will receive their treatments as prescribed by their doctors during routine practice according to the approved product information. The data will be from participants who will be identified for the survey using last 12-months data from the database called HealthCore Integrated Research Database (HIRD). The data will be collected for each participant for 12 months before the participant starts the survey. The study will end as soon as the planned number of surveys has been reached or at the end date of the study.

NCT ID: NCT05471505 Completed - Clinical trials for Non-valvular Atrial Fibrillation

Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding

Start date: August 25, 2022
Phase:
Study type: Observational

- The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database. - Atrial fibrillation (AF) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots. - An anticoagulation therapy is a critical treatment to prevent thromboembolism in NVAF patients. - Apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF in Phase 3 clinical trial. - Previously we have shown that bleeding risks as well as stroke/SE risks are less in real world clinical practice in Japan compared to warfarin. However there are limited apixaban data for Japanese NVAF patients with high bleeding risk(s). - This study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in Japanese patients with NVAF who has higher chance of bleeding

NCT ID: NCT05468281 Completed - Atrial Fibrillation Clinical Trials

RAFF5 Proposal: Improve the Quality and Safety of Patients Seen in the Emergency Department for Acute Atrial Fibrillation and Flutter

RAFF5
Start date: September 1, 2022
Phase:
Study type: Observational

Acute atrial fibrillation (AF) and flutter (AFL) are the most common arrhythmias requiring management in the emergency department (ED). They are characterized by sudden onset of a rapid heart rate which may be irregular (AF) or regular (AFL). Our focus is on episodes of acute AF or AFL which are usually less than 48 hours in duration and are highly symptomatic, requiring rapid treatment in the ED. Management guidelines for acute AF/AFL have changed substantially in recent years with several recent revisions published by the Canadian Cardiovascular Society (CCS) and the Canadian Association of Emergency Physicians (CAEP). The 2021 CAEP Acute Atrial Fibrillation/Flutter Best Practices Checklist (CAEP Checklist) was very recently published to assist ED physicians in Canada and elsewhere manage patients who present to the ED with acute AF/AFL (Figure 1). The overall goal of this project is to improve the quality and safety of the immediate and subsequent care of patients seen in the ED with acute AF and AFL by implementing the principles of the CAEP Checklist at both The Ottawa Hospital (TOH) EDs and by working with TOH cardiologists to provide rapid cardiology follow-up processes for patients discharged from the ED. The Investigators propose a before-after cohort study using an interrupted time series design to evaluate implementation involving 720 patients at the two TOH EDs over a 24-month period.

NCT ID: NCT05461859 Completed - Clinical trials for Atrial Fibrillation Paroxysmal

Cardioneuroablation for the Treatment of Vagally-mediated Atrial Fibrillation.

Start date: March 16, 2020
Phase:
Study type: Observational

Pulmonary vein isolation (PVI) is a cornerstone for catheter ablation of atrial fibrillation (AF), however, exact mechanisms of PVI efficacy remain debatable. It has been postulated that in patients with increased vagal tone AF can be treated by attenuation of parasympathetic drive to the heart using cardioneuroablation (CNA) by means of radiofrequency (RF) of the ganglionated plexi, however, data in literature and guidelines are lacking. The objective of this study is to examine the mid-term efficacy of RF-CNA targeting the right anterior ganglionated plexus (RAGP) in management of AF using right-atrial approach only.

NCT ID: NCT05459831 Completed - Atrial Fibrillation Clinical Trials

Efficacy Comparison of High and Very High Power Short Duration Pulmonary Vein Isolation

HPSD-Remap
Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Objective: To evaluate the long-term durability of PVI performed with 90W and 50W (QDot catheter). Primary hypothesis: Pulmonary vein isolation performed with 90W (QMODE+) and inter-tag distance <5 mm is non-inferior to pulmonary vein isolation performed with 50W guided by ablation index (QMODE) and inter-tag distance <5 mm. Study Design: 40 patients will be randomized in a 1:1 ratio to 50W and 90W PVI. Study procedures: Initial PVI will be performed via femoral access and double transseptal puncture guided by fluoroscopy and pressure monitoring. If necessary intracardiac echocardiography (ICE) will be used for the transseptal puncture. A fast anatomical left atrial map will be created with a multipolar mapping catheter; then, point-by-point PVI will be performed with QDot catheter with 50W or 90W according to randomization. Three months after the initial procedure, patients will undergo a repeated high density left atrial mapping with PentaRay or OctaRay catheter to evaluate the durability of the PVI. Exact gap numbers and locations will be registered. If necessary, reablation of the pulmonary veins (rePVI) will be performed. Inclusion criteria: Symptomatic paroxysmal/persistent AF, >18 years, willingness to sign informed consent form. Exclusion criteria: Long-standing persistent AF, active malignancy, contraindication for anticoagulant therapy, life expectancy <1 year, valvular AF, hyperthyroidism. Endpoints: At repeat procedure, a high density left atrial map will be created with PentaRay or if available OctaRay catheter to evaluate the durability of the PVI. Primary endpoint will be pulmonary vein reconnection.

NCT ID: NCT05450731 Completed - Atrial Fibrillation Clinical Trials

Cardiac Rehab Post-atrial Fib Ablation

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

The aim of this study is to examine the effect of a 12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in patients at six- and twelve-months post-ablation procedure.

NCT ID: NCT05449158 Completed - Atrial Fibrillation Clinical Trials

The Relationship Between Left Atrial Pressure and Cardiac Function After Atrioventricular Node Ablation

LAP-TOP
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing