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Atrial Fibrillation clinical trials

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NCT ID: NCT06330480 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease

Start date: September 2024
Phase: N/A
Study type: Interventional

The aim of the Check@Home consortium is to set up a roadmap and infrastructure for a program to early detect atrial fibrillation and chronic kidney disease in the general population. This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven). In total, a random sample of 160,000 people (aged 50-75 years) will be invited to participate in the study and another random sample of 160,000 people with the same characteristics will be included in the control group in which no screening will be offered. The overall screening program will consist of three phases: a home-based testing phase, diagnostic screening phase, and a treatment phase: - Phase 1: Subjects will be invited for a home-based screening that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation. - Phase 2: Depending on the results on these home-based tests, subjects will be invited for further screening in a diagnostic screening facility. During this visit, physical data will be collected (height, weight, waist circumference, blood pressure, heart rhythm), blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that include questions on demographics, educational level, disease history, medication use, health literacy, and quality of life. - Phase 3: Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines. The primary study outcomes are: Overall effectiveness of population based screening on atrial fibrillation and chronic kidney disease in subjects aged 50-75 years, based on: - Participation rate of different screening strategies and phases; - Yield of the screening (number of subjects with (newly) diagnosed disease and risk factors); - Effectiveness of the atrial fibrillation screening, compared with standard care, based on the incidence of ischemic stroke); - Effectiveness of the albuminuria screening, compared with standard care, based on the incidence of kidney failure events and Major Adverse Cardiovascular Events (MACE).

NCT ID: NCT06327425 Not yet recruiting - Atrial Fibrillation Clinical Trials

MCG for Localization of Tachyarrhythmia's Origin

Start date: March 14, 2024
Phase: N/A
Study type: Interventional

This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation.

NCT ID: NCT06324188 Not yet recruiting - Atrial Fibrillation Clinical Trials

Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

Start date: June 2024
Phase: N/A
Study type: Interventional

EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial). The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.

NCT ID: NCT06322017 Not yet recruiting - Atrial Fibrillation Clinical Trials

Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation

EDearly AF
Start date: March 20, 2024
Phase: N/A
Study type: Interventional

Therapeutic management of Atrial Fibrillation (AF) is based either on heart rate control or on rhythm control, a strategy which aims to maintain a normal heart rhythm. The benefit in terms of morbidity and mortality of a normal heart rhythm would, however, be largely offset by the frequent side effects of antiarrhythmic drugs which could even lead to an increase in mortality compared to rate control. This increase has particularly been suggested in people aged over 75. Since the emergence of catheter Pulmonary Vein Isolation (PVI), an effective alternative to antiarrhythmic drugs has become available. This technique makes it possible to isolate the foci triggering AF under local or general anesthesia with greater effectiveness than medications and very low risks. Records in the elderly do not seem to show a reduction in effectiveness or an increase in complications. However, in the absence of a dedicated randomized study, its use is strongly limited in the elderly where rate control (52% of people over 65 years old) and the use of antiarrhythmic drugs are largely favored due to the simplicity of implementation and the low cost of medications. However, an early rhythm control strategy seems to reduce cardiovascular events in relatively old individuals (average age 70 years). The use of PVI in first line could make it possible to further improve these results. The objective of the investigator is therefore to carry out the first randomized comparative study proposing to evaluate the impact of early PVI compared to usual treatment in patients aged 75 and over with AF.

NCT ID: NCT06315192 Not yet recruiting - Atrial Fibrillation Clinical Trials

Stroke Alarm Efficacy Trial

StrokeAlarmEFF
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset. This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population. A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size. Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study. Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by: 1. recent TIA, OR 2. recent stroke without persisting arm motor deficit, OR 3. atrial fibrillation A control population matched for age, sex, NIHSS score and health care region will be identified in the Swedish national stroke registry, Riksstroke, and used for comparison. The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard.

NCT ID: NCT06308094 Not yet recruiting - Atrial Fibrillation Clinical Trials

320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation.

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. The study will assess if higher ECV levels correlate with increased risks of AF recurrence, hospitalization, and poor cardiac function recovery. Positive findings could make ECV a key factor in deciding AF treatment strategies.

NCT ID: NCT06299514 Not yet recruiting - Heart Failure Clinical Trials

RAFT-P&A Randomized Control Trial

Start date: March 10, 2024
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy.

NCT ID: NCT06293430 Not yet recruiting - Atrial Fibrillation Clinical Trials

Registry on Luma Vision's VERAFEYE System (ENLIgHT)

ENLIgHT
Start date: September 15, 2024
Phase:
Study type: Observational

The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures. Results from this study will be used to guide development of the VERAFEYE System.

NCT ID: NCT06286111 Not yet recruiting - Atrial Fibrillation Clinical Trials

Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries

Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF

NCT ID: NCT06282380 Not yet recruiting - Atrial Fibrillation Clinical Trials

Fibricheck Detection cApabilities for Atrial Fibrillation

FDA-AF
Start date: March 2024
Phase: N/A
Study type: Interventional

Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.