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Atrial Fibrillation clinical trials

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NCT ID: NCT05690009 Recruiting - Hypertension Clinical Trials

Real Clinical Practice Register of AlbUminuRia Detection in Patients With Previously undiAgnosed Chronic Kidney Disease

AURA
Start date: February 27, 2023
Phase:
Study type: Observational [Patient Registry]

Real clinical practice register of Albuminuria detection in patients with previously undiagnosed chronic kidney disease

NCT ID: NCT05687591 Recruiting - Atrial Fibrillation Clinical Trials

Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study

Start date: October 1, 2022
Phase:
Study type: Observational

This is a prospective and retrospective, multicenter observational study where the study is being performed to explore on the short-term and long-term safety and efficacy of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population on a real-world basis.

NCT ID: NCT05679024 Recruiting - Stroke Clinical Trials

Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation

SACK
Start date: February 17, 2023
Phase: Phase 3
Study type: Interventional

Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events. The secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation. Trial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months. Trial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)* <20 ml/min/1.73 m2 at least twice 3 months apart of which at least one occasion is <15 ml/min/1.73 m2 due to CKD during the last 12 months) and a diagnosis of chronic, paroxysmal, persistent, or permanent AF or atrial flutter (AFL) with CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation. The exclusion criteria are AF or AFL due to reversible causes, rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study, a condition other than AF or AFL that requires chronic anticoagulation, contraindications for anticoagulation, active bleeding or serious bleeding within 3 months, planned for surgery within 3 months, and current use of strong inhibitors of both CYP3A4 and P-glycoprotein. Interventions: Randomization 1:1 to treatment with apixaban 2.5 mg twice daily and standard of care, or standard of care and no anticoagulation. Outcome measures: primary efficacy (time to first ischemic stroke); primary safety (the composite of time to first intracranial bleeding or fatal bleeding); secondary efficacy (time to all-cause mortality, time to cardiovascular event or cardiovascular death); secondary safety (time to first major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria)

NCT ID: NCT05677516 Recruiting - Atrial Fibrillation Clinical Trials

Incidence and Duration of Unintentional Neuromodulation Effects After Pulmonary Vein Isolation in Patients With Atrial Fibrillation.

UNCOVER-PVI
Start date: December 23, 2021
Phase:
Study type: Observational [Patient Registry]

Pulmonary vein isolation (PVI) is a proven, high-efficiency treatment for atrial fibrillation (AF). Performed, among others, using cryoablation, pulsed field ablation (PFA) or radiofrequency (RF) ablation. It has been shown that its effectiveness significantly increases when the PVI procedure is combined with cardioneuroablation (CNA). The autonomic nervous system - ganglionated plexi (GP), the target of the CNA, are the endings of the vagal nerve and are located in the neighborhood of the pulmonary veins ostia. Places that, in many cases, are unintentionally damaged during PVI. Varying degrees of injury to the GP during PVI indicate that the group of patients undergoing PVI is heterogeneous in this regard, and the effectiveness of PVI may vary. Vagal nerve endings damage during CNA abolishes or modifies its activity, which is manifested by the acceleration of sinus rhythm and increased atrioventricular conduction efficiency. Unintended CNA is not observed in every PVI procedure. The severity of the unintended CNA effect and its duration also vary. THE STUDY OBJECTIVES: 1. Frequency of unintentional CNA occurrence during PVI 2. Duration effect of CNA after unintentional CNA 3. Evaluation of the relationship between the different kinds of energy - cryo, pulsed field) and RFwith the unintentional CNA frequency occurrence and durability effect 4. Clinical significance evaluation of the new assessment method of the CNA effectiveness with the measure of the cSNRT and the sinus rate after its return, measured before and after PVI 5. Assessment of clinical significance for CNA evaluation of the electrophysiological parameters of AV node conduction efficiency, such as PQ interval, AH interval, HV interval, and Wenckebach's point. Parameters will be examined before and after PVI. 6. PVI efficacy evaluation with the AF and Sick Sinus Syndrome treatment, especially with the elimination of the indications for the PM implantation (sinus bradycardia, AV conduction disorders) 7. Assessment of sinus rhythm maintenance after PVI with unintentional CNA and without unintentional CNA 8. Assessment of ventricular rate control during AF burden after unintentional CNA 9. The search for new parameters evaluating the effectiveness and degree of CNA, such as the change in SR frequency after its return, may prove helpful and allow for resignation or significantly reduce the use of the complicated protocol of extracardiac vagal ganglion stimulation (ECVS) as a method to verify the effectiveness CNAs.

NCT ID: NCT05674253 Recruiting - Clinical trials for Atrial Fibrillation New Onset

Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New Onset AF After CABG Surgery

Start date: December 25, 2022
Phase: Early Phase 1
Study type: Interventional

Atrial fibrillation (AF) occurs in 20% to 40% of patients after Coronary artery bypass grafting (CABG) and is associated with numerous detrimental sequelae. In postoperative period, the patient may be exposed to several proarrhythmogenic factors as increased endogenous catecholamines, inflammatory and oxidative mediators secondary to surgical stress and the systemic response to cardiopulmonary bypass, use of inotropic support. Steroids suppress the release of the above-mentioned inflammatory mediators. Dexmedetomidine is sympatholytic, along with anti-inflammatory properties. so combined use of both drugs may have synergistic effect to prevent post operative AF (POAF)

NCT ID: NCT05671276 Recruiting - Atrial Fibrillation Clinical Trials

Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion

Start date: February 1, 2022
Phase: Phase 4
Study type: Interventional

The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.

NCT ID: NCT05669417 Recruiting - Clinical trials for Atrial Fibrillation New Onset

Peri-Operative Magnesium Infusion to Prevent Atrial Fibrillation Evaluated.

POMPAE
Start date: August 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Post-operative atrial fibrillation (POAF) is commonly observed in patients post cardiac surgery without a previous history of atrial fibrillation (AF) or other arrythmias. It's associated with significant postoperative complications including infection, bleeding reoperation, increased hospital length of stay (LOHS) and mortality. Magnesium has been identified as a potentially interesting compound with easy access and low toxicity. Hypomagnesemia has been observed frequently immediately after cardiac surgery. Both reduction of abnormal atomicity of atrial myocardium and prolongation of the atrial refractory period caused by administration of magnesium may prevent AF. The POMPAE trial will analyse the effectiveness of MgSO4 versus placebo (double blind randomized trial) in the prevention of POAF after cardiac surgery.

NCT ID: NCT05664308 Recruiting - Atrial Fibrillation Clinical Trials

Interest of a Hybrid Connected Watch for Cardiac Rhythm Monitoring in Post-operative Cardiac Surgery

MONHYCARD
Start date: March 19, 2024
Phase:
Study type: Observational

The objective of this single-center pilot study is, with the help of a connected watch, to show the absence of recurrence or maintenance of sinus rhythm in patients with a Post Operative Atrial Fibrillation (POAF) and to help treating cardiologists in the care of these patients.

NCT ID: NCT05661942 Recruiting - Clinical trials for Hypotension Drug-Induced

Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate

AFF RVR
Start date: November 30, 2022
Phase: Phase 4
Study type: Interventional

To compare the relative efficacy for calcium pre-treatment in decreasing incidence of drug induced hypotension after diltiazem administration for treatment of AFF with RVR. Null Hypothesis: There will be no difference between groups in incidence of hypotension after pretreatment with calcium prior to bolus of diltiazem.

NCT ID: NCT05660811 Recruiting - Atrial Fibrillation Clinical Trials

Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed Patients

SAFE LAAC CKD
Start date: September 28, 2022
Phase: Phase 4
Study type: Interventional

SAFE-LAAC CKD Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device in patients with the end-stage renal disease treated with chronic haemodialysis or peritoneal dialysis