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553 active trials for Atrial Fibrillation

DNA Methylation Analysis in Acute Coronary Syndrome and Atrial Fibrillation: DIANA Clinical Trial

Although epigenetics has been identified as one of the most relevant pathophysiological components in the development of cardiovascular diseases, there is still considerable difficulty in finding markers of epigenetic damage useful in clinical practice. Moreover, these markers could be useful to predict the onset and severity of disease as well as to stratify stratification the prognostic risk during the follow-up. The aim of this project will be to evaluate the genome wide DNA methylation status in circulating CD4+ T cells and CD8+ T cells in patients with acute coronary syndromes (ACS), atrial fibrillation (AF) and with ACS in the presence of AF.

Start: March 2019

Optimal Anticoagulation for Higher Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial

This trial is comparing medical approaches for stroke prevention in people who have atrial fibrillation (AF) and have undergone a successful procedure called ablation to eliminate or substantially reduce the arrhythmia. AF is normally associated with an increased risk of stroke which in many patients can be prevented with appropriate blood thinner therapy. This trial will compare a strategy of oral anticoagulant therapy after successful ablation to therapy with an aspirin per day.

Start: January 2016

A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation

Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (AF) ablation procedures with and without use of the Sentinel Device.

Start: May 2021

AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE

The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvular atrial fibrillation (AF). The primary objective of the study is to evaluate the efficacy of Aspirin versus Aspirin + Clopidogrel after LAAC by comparing the occurrence of ischemic lesions on cerebrovascular magnetic resonance imaging (MRI) studies.

Start: April 2021

Atrial Fibrillation in Active Cancer Patients

Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. The objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.

Start: September 2021

Systematic Evaluation of Ablation Techniques for Non-Paroxysmal Atrial Fibrillation.

The purpose of this study is to evaluate the safety and effectiveness of empirical posterior wall isolation (PWI), left atrial appendage electrical isolation (LAAEI) and coronary sinus isolation (CSI) when compared to pulmonary vein isolation (PVI) alone: PVI alone, PVI + PWI, PVI + PWI + LAAEI, PVI + PWI + LAAEI + CSI.

Start: January 2020

PCORI Integrated Care (IC) Models for Patient-Centered Outcomes

Multiple chronic conditions (MCC) are widely recognized as the U.S. public health challenge of the 21st century. These physical and behavioral health conditions take a large toll on those suffering from the diseases, including many who are publicly insured, as well as caregivers and society. While evidence-based integrated care models can improve outcomes for individuals with MCC, such models have not yet been widely implemented. Insurance providers/payers have innovative system features that can be used to deploy these models; however, the investigators do not yet know which of these features can best help to improve outcomes for individuals with MCC in general or high-need subgroups in particular. As a result, patients lack information to make important decisions about their health and health care, and system-level decision makers face ongoing challenges in effectively and efficiently supporting those with MCC. This real-world study will provide useful information about available options for supporting individuals with MCC. Building on existing integrated care efforts, the investigators will enroll N=1,927 (N=265 Phase I and N=1,662 Phase II) adults with MCC at risk for repeated hospitalizations and assess the impact of three payer-led options (e.g. High-Touch, High-Tech, Usual Care) on patient-centered outcomes, namely patient activation in health care, health status, and subsequent re-hospitalization. The investigators will also determine which option works best for whom under what circumstances by gathering information directly from individuals with MCC through self-report questionnaires, health care use data, and interviews.

Start: April 2018

A Study on the Impact of Rabeprazole-induced Elevated Stomach pH on APO-Dabigatran Exposure in Healthy Volunteers

Open-label, crossover study recruiting 46 healthy male volunteers comparing the absorption of APO-dabigatran 150 mg per oral (PO) in the absence or presence of a proton pump inhibitor. Participants will serve as their own control when comparing dabigatran exposure in the absence or presence of the proton pump inhibitor, Rabeprazole 20 mg.

Start: January 2020

Effect of Wearable Devices on Patient-Reported Outcomes and Clinical Utilization

This will be a prospective multi-center, randomized, controlled trial of 150 patients conducted to assess the impact of individual use of the Apple Watch compared to the Withings Move on patient-reported and clinical outcomes at 6 months and up to 1 year.

Start: April 2021

Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial Fibrillation

The study results will be used to check the hypothesis that CareLink Express remote monitoring system increases the detection rate of asymptomatic AF and allows to change timely the treatment strategy in patients at high risk of thromboembolic events, e.g. anticoagulation therapy onset, electrical cardioversion or/and PVI.

Start: September 2017

Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of atrial fibrillation (AF) on the burden of AF during 12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 100 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients.

Start: June 2021

A Study of the Acceptability and Performance of Wearables for Atrial Fibrillation Screening in Older Adults

--- Background and study aim Atrial fibrillation (AF) is an irregular heart rhythm which causes a five-fold increase in the risk of stroke. Approximately one in ten people aged over 70 have AF. If AF is recognised then the risk of stroke can be reduced by taking tablets regularly. AF can be difficult to recognise as it can occur without symptoms and only intermittently. Consequently, AF is not recognised in many people, meaning they live with an increased risk of stroke. Therefore, it is important to find ways to identify AF more reliably. Recently, wearable devices have been developed which could be useful for identifying AF. Several devices can monitor heart activity in daily life, including wristbands, smart watches and chest patch monitors. The aim of this study is to assess the acceptability and performance of wearables for use in AF screening in older adults. The primary objective is to determine the feasibility of measuring inter-beat-intervals using a wristband. The secondary objectives are: (i) to determine the acceptability of wearables; (ii) to determine the acceptability of the screening approach; (iii) to assess the performance of wearables for acquiring signals; (iv) to assess the performance of signal processing algorithms; and (v) to assess the performance of wearables for AF screening. --- Who can participate? Selected people who have previously participated in the SAFER Programme can participate in this study. The Investigators will invite previous SAFER Programme participants to also participate in this study, aiming to enrol 65 without AF, and 65 with AF. --- What does the study involve? Participants will be asked to wear three devices for seven days: Two wristbands (like watches), and one chest patch (like a plaster). These devices will collect measurements of their heart's activity. The Investigators will also ask participants to tell them how they found wearing the devices by completing a questionnaire. The Investigators will compare how participants found wearing each device, and how accurately each device identifies AF. --- What are the possible benefits and risks of participating? There will be no direct benefit to participants, although this research is intended to benefit future patients like them. Some participants may experience irritation or redness whilst wearing a chest patch - participants will be advised that if this occurs then they should remove it straightaway.

Start: April 2021

Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.

Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial fibrillation

Start: February 2016

Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation

In this prospective, randomized, controlled, unblinded, mono-center study, we aim to evaluate the efficacy of vein of Marshall ethanol infusion during left atrial linear ablation in patients with atrial fibrillation compared to the ALINE protocol.

Start: October 2019

Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.

The trajectory of atrial fibrillation (AF) patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the AF incidence, mortality and case-fatality, the investigators implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident AF.

Start: January 1998

Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI Pilot)

Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation. This pilot study will assess whether a randomized, placebo-controlled, double-blind trial investigating a 10-day treatment with colchicine, a potent anti-inflammatory drug, to improve patient relevant outcomes after catheter ablation for atrial fibrillation is feasible.

Start: January 2020

D-Dimer-based Indication for Transesophageal Echocardiography to Exclude Left Atrial Thrombus Before Cardioversion of Non-anticoagulated Atrial Fibrillation: A Multicenter Belgian Study

This trial aims at evaluating the number of thromboembolic events post cardioversion in patients receiving a direct current cardioversion with either prior transesophageal echocardiography or D-Dimer (DD) analysis. Patients in need of a direct current cardioversion (DCCV), meeting the criteria for DCCV with prior transesophageal echocardiography (TEE), will be asked to participate in the CARDDI-BEL study. Patients will be randomized on a 1:1 ratio to the TEE-group or DD-group. Patients in the TEE-group will receive TEE prior to cardioversion to exclude left atrial thrombus according to current guidelines [1]. In patients randomized to the DD-group, D-Dimer will be analyzed (cut-off defined by DDage). If the DDage > 10x patient's age, the analysis is suggestive for the presence of left atrial thrombus and the cardioversion will be performed with prior TEE. In case of negative DDage, no TEE will be used in the DD-group.

Start: January 2022

An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation

The objective of this prospective, multi-center trial is to assess the effectiveness of the CARILLON Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR)

Start: October 2020

Atrial Fibrillation in Cryptogenic Stroke and TIA

Background: Different studies with real-life data and randomized controlled trials have shown a detection rate of paroxysmal atrial fibrillation (AF) of 10-20% in patients with cryptogenic stroke using insertable continuous cardiac monitoring for 6 months. More studies are needed, however, to identify factors which can be used to select the patients where the possibility of detecting AF with prolonged rhythm monitoring is highest, to evaluate the best duration of rhythm monitoring, to determine the optimal de?nition of short-term AF that warrants intervention and to evaluate whether intervention results in improved clinical outcomes. Methods: The NOR-FIB study is a multi-centre prospective observational trial, designed to evaluate detection of AF in cryptogenic stroke and transient ischemic attack (TIA). Patients admitted with cryptogenic stroke or TIA in stroke units in the Nordic countries, aged 18-80 years are included and have the Reveal LINQ® Insertable cardiac monitor system implanted for 12 months for the purpose of AF detection. Biomarkers that may identify patients, who could derive the most clinical benefit from the detection of AF by prolonged monitoring, are being studied. Conclusion: This NOR-FIB study will increase our knowledge regarding the occurrence of AF in patients with cryptogenic stroke and TIA that potentially can improve secondary prevention. The study will provide information on biomarkers that may be used to select cryptogenic TIA and stroke patients for long-term monitoring as well as information on the significance of short-term AF and optimal duration of cardiac rhythm monitoring.

Start: December 2016

Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.

Protocol synopsis Sponsor: Oslo University Hospital Title: Fibrosis, inflammation and cerebral infarction in patients with atrial fibrillation Study Design: The study is an observational prospective study of atrial fibrillation patients undergoing direct-current cardioversion. Primary Objective: To assess the prevalence and causes of new silent cerebral ischemic lesions after programmed direct-current cardioversion using diffusion-weighted sequences in brain MRI (DWMRI). Secondary Objectives: To study the impact of inflammation measured by biomarkers and cardiac 18F-FDG-PET on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF. To assess the impact of fibrosis measured by biomarkers on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF. To assess cognitive and cerebral structural and metabolic changes after direct-current cardioversion for AF using cognitive assessments and cerebral and cardiac 18F-FDG-PET before and 12 months after treatment. Number of Subjects: 50 Study Centers: Østfold Hospital Trust Duration of Study Participation: Enrollment: 18 months Follow-up period: 12 months Total Study Duration: 30 months Primary Endpoints: • Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion. Secondary Endpoints: Rate of AF recurrence within 1 year after direct current cardioversion Change in levels of inflammation biomarkersfrom baseline to 12 months follow-up Change in levels of fibrosis biomarkers from baseline to 12 months follow-up Cognitive function at 12 months follow-up Changes in uptake pattern on cerebral 18F-FDG-PET from baseline to 12 months follow-up Changes in uptake pattern on cardiac 18F-FDG-PET from baseline to 12 months follow-up Brain volume at 12 months follow-up White matter volume 12 months follow-up Grey matter volume 12 months follow-up Cortical volume 12 months follow-up RSI-derived diffusion parameters 12 months follow-up: fast apparent diffusion coefficient, extracellular water fraction, fractional anisotropy; free water fraction; intracranial volume; NAWM: normal appearing white matter; neurite density; RSI: restriction spectrum imaging; sADC: slow apparent diffusion coefficient;restricted fractional anisotropy; white matter lesions.

Start: March 2018