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Atrial Fibrillation clinical trials

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NCT ID: NCT06465459 Recruiting - Atrial Fibrillation Clinical Trials

Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure

ESCALLE
Start date: June 14, 2024
Phase:
Study type: Observational [Patient Registry]

Atrial fibrillation (AF) is responsible for 15-20% of ischaemic strokes. These events are often caused by thrombus formation in the left atrium. Thromboembolic risk in AF is primarily prevented by oral anticoagulation. However, this drug-based approach has a number of limitations, the most important of which are compliance problems and, above all, the risk of haemorrhagic complications, some of which are potentially serious. Left atrial appendage closure is a therapeutic alternative for the prevention of cardioembolic risk in cases where anticoagulation is clearly contraindicated. The CNEDiMTS opinion of 12 March 2019 defines that the LAMBRE, LIFETCH prosthesis, a device for transcatheter closure of the left atrial appendage, is authorised for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation at high risk of thromboembolic events with a CHA2DS2-VASc score ≥ 4 and a formal and permanent contraindication to anticoagulants (validated by a multidisciplinary committee). LAMBRE prosthesis in France are subject to a review of the results by the CNEDIMTS committee. Among the criteria analysed regarding the efficacy and safety of the device implantation, the result regarding the migration rate of the LAMBRE device will be one of the criteria enabling the Commission to decide on the appropriateness of the renewal of the registration.

NCT ID: NCT06465134 Recruiting - Hypertension Clinical Trials

Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea

AF-MiTriSto
Start date: November 1, 2023
Phase:
Study type: Observational

Atrial fibrillation (AF) is the most common rhythm disorder and involves an increased risk of cardiovascular disease and death, impaired quality of life and a high proportion of healthcare consumption. An important risk factor is obstructive sleep apnea (OSA). However, it is not fully understood why OSA induces AF. It may be due to a proinflammatory state, sympathetic activation and acute changes in blood pressure during apnéas, but few studies are performed. Hypertension with its coherent arterial stiffness is related to all these factors, is common in OSA, and is the most common cause of AF. The cause of AF in hypertensive subjects is believed due to a pressure overloaded left heart, with dilation and fibrosis of the left atrium, promoting the development of AF. Hypertension and arterial stiffness can thus be important triggering factors for AF in OSA. In this project, teh investigators investigate the occurrence of OSA in AF patients. Furthermore, underlying mechanisms for the development and recurrence of AF after intervention in OSA patients are investigated. 300 patients scheduled for AF ablation or cardioversion are invited and examined with sleep registration, 24h blood pressure, aortic stiffness measurement, test of autonomic function, echocardiography, ECG and labs. The patients are followed at months 3, 6 and 12 with 7 days ECG for recurrence. The aim is to give insights into the need for screening for OSA in patients with AF. The study also aim at enabling preventive treatment through better understanding of underlying treatable mechanisms. The results are believed to lead to fewer new AFs, as well as fewer AF recurrences in patients with OSA.

NCT ID: NCT06455644 Recruiting - Clinical trials for Cardiovascular Diseases

Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion

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

This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion. After signing the informed consent form, the subjects will be randomly assigned to either the cardiac Computed Tomography (CT) group or the Digital Subtraction Angiography (DSA) group. The operator will select the appropriate LAA occluder size for implantation based on different measurement methods. All subjects will undergo clinical follow-up before discharge and at 3 months postoperatively, as well as telephone follow-up 1-5 years after the surgery.

NCT ID: NCT06445439 Recruiting - Clinical trials for Atrial Fibrillation, Persistent

Optimal Pacing Rate for Cardiac Resynchronization Therapy

OPT-RATE AF
Start date: December 19, 2023
Phase: N/A
Study type: Interventional

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves quality of life (QoL) and patient function after 3 months of intervention compared to 3 months of the current standard 60 bpm. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.

NCT ID: NCT06438692 Recruiting - Heart Failure Clinical Trials

Ablation Strategies for Persistent Atrial Fibrillation Combined With Heart Failure

Start date: June 16, 2022
Phase: N/A
Study type: Interventional

(1) To evaluate the efficacy and safety of "2C3L" strategy combined with VOM anhydrous ethanol chemical ablation for persistent atrial fibrillation complicated with heart failure; (2) To evaluate the effectiveness of high-efficiency ablation of atrial fibrillation complicated with heart failure.

NCT ID: NCT06436924 Recruiting - Atrial Fibrillation Clinical Trials

Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

Start date: May 30, 2024
Phase:
Study type: Observational

SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day.

NCT ID: NCT06431828 Recruiting - Atrial Fibrillation Clinical Trials

Remote Symptom Review in Patients With Implantable Diagnostic Holter

BIOMONI-DIG
Start date: April 22, 2024
Phase: N/A
Study type: Interventional

To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.

NCT ID: NCT06424171 Recruiting - Stroke Clinical Trials

AFLETES-MRI: A Cardiac and Cerebral Magnetic Resonance Imaging Study in Athletes With Atrial Fibrillation

AFLETES-MRI
Start date: January 22, 2024
Phase:
Study type: Observational

Participation in exercise improves cardiovascular health. However, long-term endurance exercise may increase the risk of an irregular heart rhythm called atrial fibrillation (AF). In AF, blood flow is altered, increasing the risk of clot formation in the heart which may enter the circulation and cause a stroke. The risk of stroke can be reduced with the use of blood thinning medication. Athletes with atrial fibrillation, due to their healthy lifestyle, are generally felt to be at low risk of stroke and many would not be offered blood thinning treatment using risk scores used in clinical practice. In a recent survey of almost one thousand athletes, the investigators found that there was an increased risk of stroke in those with atrial fibrillation, even in those without other risk factors for stroke. To further investigate these findings, this study will use MRI scanning to look at the hearts and brains of athletes aged between 40-64 years old. The researchers will assess athletes with and without atrial fibrillation, as well as some athletes with atrial fibrillation who have had a stroke previously. The MRI scans will measure heart size and function as well as blood flow patterns in the heart. The study will determine whether athletes with atrial fibrillation have evidence of stroke on brain MRI and whether these are related to abnormal flow patterns. The results will help us decide whether a larger study should be performed.

NCT ID: NCT06422468 Recruiting - Atrial Fibrillation Clinical Trials

Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring

CARDS-pilot
Start date: March 21, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional clinical trial is to investigate whether combining photoplethysmography (PPG) signals with accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (AF).

NCT ID: NCT06409533 Recruiting - Atrial Fibrillation Clinical Trials

Rate Control Efficacy in Atrial Fibrillation With Rheumatic Mitral Stenosis: Lenient vs Strict Rate Control Strategies

RACE-MS
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if different types of heart rate control work to improve the clinical outcomes of patients with atrial fibrillation related to rheumatic mitral stenosis in terms of reducing hospitalizations, improving quality of life, and enhancing physical functional capacities. The two types of heart rate (HR) control are strict (resting HR of 60-80 bpm) versus lenient (resting HR of 81-110 bpm) rate control strategies. The main questions it aims to answer are: - Can lenient versus strict heart rate control reduce rehospitalization in patients with atrial fibrillation and rheumatic mitral stenosis? - Does lenient versus strict heart rate control improve the quality of life (QoL) in patients with atrial fibrillation and rheumatic mitral stenosis? - Does lenient versus strict heart rate control enhance functional capacity in patients with atrial fibrillation and rheumatic mitral stenosis? Researchers will compare strict rate control to lenient rate control to see if a particular rate control strategy is non-inferior to the other. Participants will: - Take standardized drugs as per PERKI (Indonesian Heart Association) guidelines for Atrial Fibrillation, which would be either beta-blockers, digoxin, or in combination. This standardized treatment of Atrial Fibrillation will be monitored once every month to see if the dose needs to be titrated in order to reach targeted heart rate control. - After the target of HR control is reached, the participant will be followed up every two weeks via telephone to check for any signs and symptoms. - Furthermore, after the HR target is reached, the participant will visit the cardiology outpatient clinics once every month for 3 consecutive months to see the clinical outcomes of hospitalization, QoL via SF-36 questionnaire, and functional capacities with 6MWT (6-minute walk test). - Additionally, the cardiac function would be evaluated by echocardiography at the baseline (time of enrollment) and at the end of the follow up period.