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Atrial Fibrillation clinical trials

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NCT ID: NCT03887780 Active, not recruiting - Clinical trials for Non-valvular Atrial Fibrillation (NVAF)

A Study to Evaluate the Safety and Effectiveness of Rivaroxaban (Xarelto) for Prevention of Stroke and Systemic Embolism in Indian Patients With Non-valvular Atrial Fibrillation (NVAF)

XARIN
Start date: October 3, 2019
Phase:
Study type: Observational

This study is planned to collect prospective data and evaluate the safety and effectiveness of rivaroxaban for the prevention of stroke and systemic embolism in Indian patients with NVAF when used in clinical practice under real-life conditions. The study will be conducted in routine clinical practice settings. Approximately 1000 patients from India will be enrolled in this study. Patients will be observed for maximum period of 12 months after the start of Xarelto treatment or until it is no longer possible (e.g. lost to follow-up, death, withdrawal) before the end of the observation period. The decision by the investigator to start with of Xarelto must be independent of the inclusion of a patient to the study.

NCT ID: NCT03884647 Completed - Stroke Clinical Trials

DELPHI in Subjects at Risk for Stroke and Dementia

Start date: April 1, 2020
Phase:
Study type: Observational

The DELPhi system is a software device that is used for the noninvasive evaluation of brain plasticity and connectivity. The DELPhi software uses EEG and TMS devices as accessories. Standard electro-physiological acquisition is performed using TMS to evoke regional neuronal potentials measured as EEG data. TMS-EEG data is analyzed with regards to conventional, well established characteristics of neuronal network plasticity and connectivity.

NCT ID: NCT03882021 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy

WAVE-MAP AF
Start date: August 26, 2019
Phase: N/A
Study type: Interventional

The aim is to use the GRID to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.

NCT ID: NCT03877913 Completed - Atrial Fibrillation Clinical Trials

Daily ECG Versus 7-day Holter ECG After Atrial Fibrillation Ablation

AGNES-ECG
Start date: August 27, 2018
Phase:
Study type: Observational

Introduction: The optimal method for the assessment of efficacy of ablation for atrial fibrillation (AF) has not yet been established. The symptom-based evaluation is not accurate because many AF episodes are asymptomatic. It has been well documented that the more frequent and/or longer ECG recording the more the AF recurrences are detected. However, such devices for long-term ECG monitoring as implantable loop recorders are expensive whereas external ECG monitoring is not well tolerated over a period longer than one month. The most frequently used approach is periodic 1-7 day Holter ECG monitoring, usually performed 3, 6 and 12 months after the procedure and additional standard ECG recordings when symptoms occur. Using this method, asymptomatic AF episodes occurring between Holter ECG recordings are missed. Recently, several types of external ECG recorders have been introduced, enabling good quality frequent ECG recordings and transmission via mobile phones. Only a few studies documented the usefulness of this method in detecting silent AF in a high-risk population, however, the value of short but frequent ECG recordings after AF ablation has not yet been established. In these studies, short ECG recordings performer once or twice daily detected the highest number of AF episodes. In summary, data on the optimal type of ECG monitoring after AF ablation are scarce. It seems that frequent, short ECG recordings have more diagnostic yield than 24-hour ECG monitoring, even when performed monthly, or standard care with recording ECG only when symptoms suggesting AF occur. However, the optimal mode of monitoring is not known. Such questions as whether once-a-day ECG transmission is enough and whether longer i.e. 7-day Holter ECG may be as valuable as daily ECG transmissions, remain unanswered. Aim: to compare daily ECG transmissions with repeated 7-day Holter ECG in detecting AF episodes following AF ablation. Hypothesis: daily ECG recordings have significantly higher yield in AF detection than repeated 7-day Holter ECG. Methods: The study group will consists of 50 consecutive patients undergoing AF ablation in the investigator's center. Only patient capable of maintain ISTEL recorder and transmitting ECG will be enrolled in the study (1-2 day after catheter ablation for AF). The follow-up will last 12 months. The AF detection will be performed using two recording methods in each patient. The number of 50 patients has been chosen based on the assumption that Holter ECG will detect AF recurrence in 15% of patients and daily transmission will detect AF recurrence in 38% patients (alfa error = 0.05 and beta error = 0.2). Daily ECG recordings and transmissions will be performed using the HR-2000 recorder (ISTEL, Poland). This device enables recording of 30 seconds of 6-channel ECG (I, II, III, aVR, aVL, aVF) from 4 metal electrodes build in the recorder. In order to record ECG, the device is activated by a patient and attached to the thorax, at the area of sternum. The duration of recording may vary from 30 seconds to 3 minutes, however, only 30-second recordings will be used in the present study. After recording, ECG will be transmitted using Bluetooth to patient's smartphone and then transmitted to the central station where they will be stored and analyzed. Analysis will be performed on a daily basis by an experienced ECG technician, not directly involved in patient's recruitment and treatment. The results of all recordings will be available for study team after 3, 6 and 12 months after ablation, at the time when concurrent Holter ECG recordings will be analyzed. Only in case of serious, life-threatening arrhythmias (non-sustained or sustained ventricular tachycardia, or pauses > 6 seconds) the study team will be informed immediately by a technician about the results of 30-second ECG recording in order to undertake proper action. Specifically, asymptomatic episodes of AF will not be unblinded to the study team in order not to interfere with medication and to allow continuing follow-up till next Holter ECG monitoring. The second method of ECG recording will be 7-day Holter ECG (DMS 300-4A recorders, DM Software, NV, USA) performed 3, 6 and 12 months after ablation. The patients will be allowed to record additional ECG when symptoms suggesting AF occur. This may be performed by ISTEL recorder or standard 12-lead ECG if available. At each time-point (3, 6 and 12 months) the study team will analyze all recorded ECGs and 7-day Holter ECG, and make appropriate therapeutic decisions. Anticipated results: - Daily ECG recordings will detect first AF episode faster than standard Holter monitoring. - ISTEL recorder will identify more patients with AF recurrence than standard Holter monitoring - ISTEL recorder will identify more patients with asymptomatic AF recurrence than standard Holter monitoring Definitions: AF episode - episode lasting ≥30 seconds Study period: August 2018 - August 2020

NCT ID: NCT03875131 Completed - Cognitive Change Clinical Trials

Definition, Quantification, and Utility of Biomarkers of Repetitive Brain Injury in Predicting Concussion and Other Long-Term Injury Risks in Patients With Atrial Fibrillation (Concussion AF)

Concussion AF
Start date: July 15, 2017
Phase:
Study type: Observational

This is a prospective clinical study designed to evaluate biomarkers of brain injury and dementia incidence and moderate cognitive decline rates in moderate- to high-risk atrial fibrillation patients that undergo standard of care atrial fibrillation management.

NCT ID: NCT03871933 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Autonomic Function in COPD and Risk for Atrial Fibrillation

Start date: March 1, 2019
Phase:
Study type: Observational

In the presented study, autonomic function as well as risk for atrial fibrillation will be assessed to characterize the relation between risk of atrial fibrillation and autonomic function.

NCT ID: NCT03871647 Completed - Atrial Fibrillation Clinical Trials

Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After CABG

Start date: March 11, 2019
Phase:
Study type: Observational

Postoperative Atrial Fibrillation (POAF) is one of the most common complications following coronary artery bypass grafting (CABG) occurring to 20% - 40% of patients. It is associated with prolonged hospitalization, increased hospital costs, increased complications and mortality rate. Despite the use of Beta Blockers, approximately 20% of patients develop atrial fibrillation following CABG surgery, suggesting a role for polymorphism in the genes The aim of the present study is to determine the minor allele frequency of some of the genes that affect the beta blockers' response and to determine the association between polymorphism in these genes and the occurrence of postoperative atrial fibrillation after coronary artery bypass grafting in Egyptian patients receiving perioperative beta blockers.

NCT ID: NCT03868150 Recruiting - Clinical trials for Postoperative Atrial Fibrillation

Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment

Start date: March 1, 2017
Phase: Phase 4
Study type: Interventional

Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment. Patients who are not inducible to AF will be treated with standard post-operative care. Patients will be monitored post-operatively to explore the value of intraoperative inducibility of AF to predict POAF and to evaluate whether the combination of intraoperative inducibility and precision amiodarone therapy is effective at reducing the incidence of POAF

NCT ID: NCT03867227 Completed - Atrial Fibrillation Clinical Trials

Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation

Start date: December 1, 2018
Phase:
Study type: Observational

Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation. However, to date, LAA occluder implantation is not recommended as an alternative for conservative therapy and reserved for patients with contraindications for oral anticoagulants only. In the same time, long-term follow-up of patients enrolled in clinical trials and data from registries showed that LAA occlude device implantation as an alternative to oral anticoagulation could reduce drug load, decrease complexity and cost of treatment and thus improve patients' quality of life, and potentially may reduce the risk of death. The aim of our study is to investigate the risk of all-cause death, stroke, and bleedings in patients with LAA occluder implanted as an alternative to anticoagulant therapy. Three hundred patients with atrial fibrillation will undergo LAA occluder implantation. For LAA occluder sizing transesophageal echocardiography (TEE), CT and LAA angiography will be performed. The follow-up period will be 36 months. The incidence of all-cause death, stroke, bleeding BARC≥2, device-related complications and QOL will be investigated. The patients will be followed in the clinic at three and six months, and then at 12, 24 and 36 months, the telephone calls for getting information about endpoints events will be done. Additional in clinic visits will be scheduled if the late complications will be suspected. TEE will be performed at three and six months to check for device leak, displacement and thrombosis.

NCT ID: NCT03866148 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Obstructive Sleep Apnoea and Cardiac Arrhythmias

OSCA
Start date: October 3, 2019
Phase: N/A
Study type: Interventional

This study is a prevelance trial looking at how sleep apnoea affects the heart especially heart rhythms. Previous research shows that patients suffering from sleep apnoea are much more likely to get heart disease and abnormal heart rhythms (arrhythmias). These defects are sometimes missed by the traditional methods of monitoring i.e. 24-hour Holter monitor and ECGs. This means potentially dangerous arrhythmias may not be detected. Additionally, standard therapy for sleep apnoea does not significantly reduce the risk of heart disease. This study will recruit 200 participants over a period of 18 months. The research team will observe the heart rhythms of sleep apnoea patients by inserting an implantable loop recorder (ILR) in up to 100 participants. The other 100 patients will simply have standard care. This device will monitor the heart continuously for 3 years allowing us to detect abnormal heart rhythms and treat as necessary. Demonstrating the incidence of arrhythmia can lead onto a larger study which may change future sleep apnoea management improving their cardiovascular outcomes. Other markers of heart disease such as; blood tests, Magnetocardiography and Echocardiography will be performed on participants to shed more light on the mechanisms which link sleep apnoea and heart disease/arrhythmia.