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Atrial Fibrillation clinical trials

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NCT ID: NCT05316753 Recruiting - Atrial Fibrillation Clinical Trials

BTE and Pulsed Waveforms for Cardioversion of Atrial Fibrillation - Escalation Strategy and Manual Pressure

Start date: January 20, 2022
Phase: N/A
Study type: Interventional

Background: A Danish study raised the question of the usefulness of escalating energy protocols compared to fixed high-energy protocols. Maximal energies are usually the final choice of the physicians. Some authors showed that decreasing impedance by manual pressure application (MPA) had a positive impact on cardioversion outcome. This is likely due to the impedance decrease linked to MPA. Objective: This new clinical cardioversion study of atrial fibrillation (AF) patients aims to compare the efficacy and safety of a new high energy escalation strategy. The protocol combines high energy shocks at first shock, jumping to maximal defibrillator energy at second shock and finally complemented by MPA at third shock, if success is not reached using electric shocks only. Experimental design: Patients will be recruited at the Intensive Cardiology Care Unit, Cardiology Clinic, National Cardiology Hospital (NCH), Sofia, Bulgaria. All eligible patients will sign a written informed consent prior to the cardioversion and will receive the standard hospital procedures during cardioversion. AF patients will be alternatively randomized to cardioversion using one of the two defibrillators, following the strategy below: DEFIGARD HD-7 arm: 3 consecutive shocks with escalating selected energy: 150J, 200J, 200J. The third shock is combined with MPA LIFEPAK15 arm: 3 consecutive shocks with escalating selected energy: 150J, 360J, 360J. The third shock is combined with MPA The statistical power analysis will consider a superiority comparison between the cumulative energy actually delivered by both defibrillators. The secondary cardioversion efficacy outcome measures are: the cumulative success rate (measured at 1 minute post-shock), number of delivered shocks. Delivered energy will be measured during each shock with a dedicated pulse recording device (approved by the NCH Ethical Committee). Heart rhythm will be measured in continuously recorded peripheral ECG. The secondary cardioversion safety outcome measures are: markers for myocardial necrosis (high sensitive troponin I, CK-MB) evaluated on blood samples taken before and 8-12 hours after cardioversion; ST-segment changes (post-shock - pre-shock) measured in lead II; Complications after cardioversion measured during 2 hours follow-up period in the ICCU - the presence of apnea, arrhythmias, bradycardia and the need for respective therapy at the discretion of attending physician.

NCT ID: NCT05311137 Recruiting - Atrial Fibrillation Clinical Trials

Study of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population

CONTROL-AF
Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy.

NCT ID: NCT05311098 Recruiting - Atrial Fibrillation Clinical Trials

Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation

AF-PACC-CRYO
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study was to verify the safety and efficacy of routine and extended vestibular ablation in the treatment of paroxysmal/short-course persistent atrial fibrillation.

NCT ID: NCT05300997 Recruiting - Atrial Fibrillation Clinical Trials

Translational Immunodiagnostics in Stroke (TrImS)

TrImS
Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

In adult patients presenting to emergency departments within 24 hours of symptom onset with suspected acute stroke, we aim: 1. to identify early brain- and pathology-specific circulating, whole blood, plasma and serum panorOmic biomarkers that enable early acute stroke detection, diagnosis, dynamics, differentiation, monitoring, prediction and prognosis. 2. to identify early brain- and pathology-specific, panorOmic biomarkers in saliva that enable early acute stroke detection, diagnosis, dynamics, differentiation, monitoring, prediction and prognosis. 3. to derive biomarker platforms of models for early acute stroke detection, diagnosis, dynamics, differentiation, monitoring, prediction and prognosis 4. to validate these models in independent and external datasets

NCT ID: NCT05300555 Recruiting - Clinical trials for Atrial Fibrillation New Onset

Cost-effectiveness Analysis Between Two Anticoagulation Strategies for Atrial Fibrillation in the Postoperative Period of Coronary Artery Bypass Graft Surgery

TASK-POAF
Start date: January 5, 2021
Phase: Phase 4
Study type: Interventional

Coronary artery bypass graft (CABG) surgery is a common intervention in patients with coronary artery disease (CAD). The presence of new postoperative atrial fibrillation / atrial flutter (POAF) occurs in 15-40% of patients undergoing this procedure, with a high rate of complications, including increased hospital length of stay, with a consequent increase in the costs. In addition, the presence of POAF increases the rate of thromboembolic events such as stroke and mortality in the short and long term. Anticoagulant treatment in patients with atrial fibrillation and atrial flutter (AF) lato sensu is already a well-established therapy in patients at high risk, defined by CHADS-VASC greater than or equal to 2. The use of direct-acting anticoagulants (DOACS) is standard therapy for those patients. In the POAF scenario, there is a recommendation for anticoagulation in high-risk patients for at least 30 days, however, despite being an entity with a poor prognosis in the short and long term, it is an undertreated entity. At present, there is no evidence of anticoagulant treatment of POAF with DOACS, and warfarin is the standard therapy. Warfarin is a drug that needs laboratory control of prothrombin time (PT) and anticoagulation bridge with other anticoagulants, usually using heparin and enoxaparin. We believe that because warfarin is the standard drug in this scenario, it is not prescribed on a regular basis, since it increases costs, length of hospital stay and is less effective than DOACS in AF lato sensu. Thus, the research project intends to compare the cost-effectiveness, assessed by QALY, related to the warfarin prescription strategy associated with bridge anticoagulation versus the rivaroxaban prescription in patients who presented POAF with a minimum duration of 12 hours or AF that requires intervention. Medications will be started during hospitalization. After randomization, anticoagulant medication will be started within 24 hours. The patient will be reassessed in 30 days and if there is no evidence of maintenance of AF, the anticoagulant medication will be discontinued and the standard treatment for CAD will be maintained. Secondary outcomes will be: clinical outcomes, such as: (1) Death; (2) stroke; (3) myocardial infarction (MI); (4) Readmission; (5) Systemic embolization; (6); Surgical reintervention; (6) Bleeding using the ISTH score; (7) Infection. The safety outcome will be the bleeding assessment according to the bleeding score of the ISTH (International Society on Thrombosis and Haemostasis). Considering that POAF is a prevalent entity and associated with a worse prognosis in the short and long term, as well as despite recommendations for guidelines to keep these patients anticoagulated, it is noted that the prescription of anticoagulation at hospital discharge is low. Considering that there is no clear evidence in studies on the use of DOAC in this population, we understand that the search for medications that lead to better cost-benefit, as well as better dosage and bleeding rates not lower than the use of warfarin, could lead to a higher rate prescribing anticoagulants for these patients, reducing costs, clinical and mortality outcomes.

NCT ID: NCT05294445 Recruiting - Clinical trials for Atrial Fibrillation (AF)

From the Emergency Department Directly to Ablation of Atrial Fibrillation Study

EMERGE Cryo
Start date: December 15, 2021
Phase: N/A
Study type: Interventional

The study is a prospective, two-arm, randomized, open-label, blinded endpoint, multi-center study to investigate the impact of first line ablation in patients presenting at the emergency room with recent-onset paroxysmal or persistent atrial fibrillation.

NCT ID: NCT05292209 Recruiting - Clinical trials for Atrial Fibrillation Paroxysmal

RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring

SOLUTION
Start date: June 15, 2022
Phase: Phase 2
Study type: Interventional

Atrial fibrillation (AF) is a growing clinical problem.1 AF is a highly dynamic condition involving episodes of sinus rhythm interspersed with periods of arrhythmia, becoming more difficult to terminate over time. AF carries a substantial cost, morbidity and mortality burden. There are two important approaches to the management of AF: 1). Controlling ventricular response rate without attempting to terminate or prevent AF (rate control), and 2). Attempting to control and maintain sinus rhythm (rhythm control).2 Current rhythm control with antiarrhythmic agents (AAD) is only moderately beneficial in restoration and maintenance of sinus rhythm but produce serious adverse events. AAD selection is limited based on the potential for pro-arrhythmia, patient's age, presence of structural heart disease, and renal or hepatic dysfunction. All AF anti-arrhythmic agents are associated with harm (number needed to harm 17-119).3 There remains an important need for development of an efficacious safe AAD for the control of AF. Recent published translational studies suggest that that neuronal-type Na+ channel blockade (nNav) with riluzole, a nNav inhibitor used to manage amyotrophic lateral sclerosis (ALS), can effectively suppress triggered atrial arrhythmias.4 In two independent retrospective cohorts, riluzole-treated ALS patients significantly lowered the incidence of new-onset AF. Riluzole is well-tolerated without evidence of pro-arrhythmia.5 Therefore, to assess riluzole's effects on the reduction of paroxysmal episodes of AF, we will conduct a prospective, randomized, placebo-controlled human study using holter monitors that offer continuous electrocardiographic monitoring pre- (1 month) and with exposure to riluzole or placebo (1 month) to determine statistically superior reductions in episodes of AF.

NCT ID: NCT05287191 Recruiting - Clinical trials for Atrial Fibrillation New Onset

MAGNAM Trial, Magnesium Versus Amiodarone in Atrial Fibrillation in Critical Care

MAGNAM
Start date: January 5, 2022
Phase: Phase 3
Study type: Interventional

A multi-centre, non-blinded, comparative effectiveness, randomised controlled trial. Patients will be prospectively enrolled from Critical Care Units and will be assessed for study enrollment based on inclusion/exclusion criteria at the time of the onset of fast atrial fibrillation (AF)(irregular and often rapid heart rate). The authors hypothesize that high dose Magnesium Sulphate with the addition of Digoxin as a second line treatment will improve the success rate in returning the heart to normal rhythm as well as speed of resolution of critical illness in new onset rapid atrial fibrillation in the critically ill cared for in general ICUs.

NCT ID: NCT05266144 Recruiting - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Patients Treated With Catheter Ablation

Start date: September 4, 2020
Phase:
Study type: Observational

This is a single-center prospective observational cohort study of atrial fibrillation patients treated with radiofrequency ablation.

NCT ID: NCT05264831 Recruiting - Clinical trials for Persistent Atrial Fibrillation

Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure

PACIFIC
Start date: February 20, 2023
Phase: N/A
Study type: Interventional

This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation. All included patients will undergo an electric cardioversion, then: - Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients. - Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures: - PVI procedure alone - PVI procedure combined with substrate modulation