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Condition: Atrial Fibrillation
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Total 66 results found since Jan 2013.

FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine. Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news

Landmark Phase 3 VOYAGER PAD Study of XARELTO ® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefit using...
Source: Johnson and Johnson - March 28, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients. Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien 3 transcatheter aortic valve replacements compared the TAVR treatments with traditional open surgery in the intermediate-risk cohort (both of the Edwards valves are already approved in the U.S. for high-risk patients). Sapien XT non-inferior to surgery at 2...
Source: Mass Device - April 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news

Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Atrial fibrillation (AF) pilot screening programme in primary care in Ireland: an implementation study protocol
This study aims to investigate the acceptability, feasibility and impact of AF screening in primary care using a handheld mobile ECG device. Methods and analysis General practitioners (GPs) and practice nurses in the South of Ireland will opportunistically screen patients aged ≥65 years for AF at routine consultation using a handheld one-lead ECG device, KardiaMobile. This study will screen up to 4000 patients. Blood pressure and smoking status will be checked concurrently. A mixed-method evaluation will be undertaken including a partial economic evaluation. Anonymised data will be collected from participating practice...
Source: BMJ Open - February 7, 2022 Category: General Medicine Authors: Callanan, A., Quinlan, D., O'Sullivan, S., Bradley, C. P., Kearney, P. M., Murphy, A., Buckley, C. M. Tags: Open access, Public health Source Type: research

Direct thrombin inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in people with non-valvular atrial fibrillation.
CONCLUSIONS: DTIs were as efficacious as VKAs for the composite outcome of vascular death and ischaemic events and only the dose of dabigatran 150 mg twice daily was found to be superior to warfarin. DTIs were associated with fewer major haemorrhagic events, including haemorrhagic strokes. Adverse events that led to discontinuation of treatment occurred more frequently with the DTIs. We detected no difference in death from all causes. PMID: 24677203 [PubMed - as supplied by publisher]
Source: Cochrane Database of Systematic Reviews - March 27, 2014 Category: Journals (General) Authors: Salazar CA, Del Aguila D, Cordova EG Tags: Cochrane Database Syst Rev Source Type: research

Protocol for validating cardiovascular and cerebrovascular ICD-9-CM codes in healthcare administrative databases: the Umbria Data Value Project
Introduction Administrative healthcare databases can provide a comprehensive assessment of the burden of diseases in terms of major outcomes, such as mortality, hospital readmissions and use of healthcare resources, thus providing answers to a wide spectrum of research questions. However, a crucial issue is the reliability of information gathered. Aim of this protocol is to validate International Classification of Diseases, 9th Revision—Clinical Modification (ICD-9-CM) codes for major cardiovascular diseases, including acute myocardial infarction (AMI), heart failure (HF), atrial fibrillation (AF) and stroke. Method...
Source: BMJ Open - March 29, 2017 Category: Journals (General) Authors: Cozzolino, F., Abraha, I., Orso, M., Mengoni, A., Cerasa, M. F., Eusebi, P., Ambrosio, G., Montedori, A. Tags: Open access, Cardiovascular medicine, Health informatics, Health services research, Public health Protocol Source Type: research

Case 4–2015
ATRIAL FIBRILLATION (AF) is the most common cardiac arrhythmia in the world and is estimated to affect more than 3 million people in the United States, with a projected increase to more than 5 million people in the US by the year 2050.1 AF is an independent risk factor for stroke and is associated with a four- to five-fold increased risk of embolic stroke compared with those individuals without AF. Oral anticoagulation therapy with warfarin or other agents (dabigatran, apixaban) significantly reduces the risk of stroke in this population; however, anticoagulation carries inherent risks.
Source: Journal of Cardiothoracic and Vascular Anesthesia - March 18, 2015 Category: Anesthesiology Authors: Megan J. Lanigan, Mark A. Chaney, Sandeep Nathan, Atman P. Shah, Andrew J. Feider Tags: Case Conference Source Type: research

Comparison of treatment effect estimates of non-vitamin K antagonist oral anticoagulants versus warfarin between observational studies using propensity score methods and randomized controlled trials
In this study, treatment effect estimates of NOACs versus warfarin in patients with non-valvular AF from PS studies are found to be in agreement with those from RCTs.
Source: European Journal of Epidemiology - June 30, 2016 Category: Epidemiology Source Type: research

Opportunistic screening to detect atrial fibrillation in Aboriginal adults in Australia
Introduction There is a 10-year gap in life expectancy between Aboriginal and non-Aboriginal Australians. The leading cause of death for Aboriginal Australians is cardiovascular disease, including myocardial infarction and stroke. Although atrial fibrillation (AF) is a known precursor to stroke there are no published studies about the prevalence of AF for Aboriginal people and limited evidence about AF in indigenous populations globally. Methods and analysis This mixed methods study will recruit and train Aboriginal health workers to use an iECG device attached to a smartphone to consecutively screen 1500 Aboriginal peopl...
Source: BMJ Open - November 14, 2016 Category: Journals (General) Authors: Gwynne, K., Flaskas, Y., O'Brien, C., Jeffries, T. L., McCowen, D., Finlayson, H., Martin, T., Neubeck, L., Freedman, B. Tags: Open access, Cardiovascular medicine, Patient-centred medicine, Public health Protocol Source Type: research

Influence of decision ‐aids on oral anticoagulant prescribing among physicians: a randomized trial
ConclusionsRisks could be communicated using decision aids with only one graphic. Showing the risk of stroke at 5 years could increase the prescription of OACs to patients with AF. Faced with the same risk of stroke, physicians prescribed less to themselves than to patients.This article is protected by copyright. All rights reserved.
Source: European Journal of Clinical Investigation - July 6, 2017 Category: General Medicine Authors: Cristian Baicus, Caterina Delcea, Alina Dima, Emilia Oprisan, Ciprian Jurcut, Gheorghe Andrei Dan Tags: Original Paper Source Type: research

Influence of decision aids on oral anticoagulant prescribing among physicians: a randomised trial
ConclusionsRisks could be communicated using decision aids with only one graphic. Showing the risk of stroke at 5 years could increase the prescription of OACs to patients with AF. Faced with the same risk of stroke, physicians prescribed less to themselves than to patients.
Source: European Journal of Clinical Investigation - July 28, 2017 Category: General Medicine Authors: Cristian Baicus, Caterina Delcea, Alina Dima, Emilia Oprisan, Ciprian Jurcut, Gheorghe Andrei Dan Tags: Original Article Source Type: research

Can catheter ablation reduce the incidence of thromboembolic events in patients with atrial fibrillation?: Protocol for a systematic review and meta-analysis
Abstract Atrial fibrillation (AF), the most common cardiac arrhythmia, is a major risk factor for thromboembolic events, especially ischemic stroke. Catheter ablation is an effective method to maintain sinus rhythm in patients with AF. Although some observational studies have shown a relatively lower stroke rate after catheter ablation, whether catheter ablation can reduce the thromboembolic risk in patients with AF remains unclear. We aim to perform a systematic review to determine whether catheter ablation can prevent thromboembolism in patients with AF. PubMed, Embase, the Web of Science, and the Cochrane Library wil...
Source: Medicine - December 1, 2017 Category: Internal Medicine Tags: Research Article: Study Protocol Systematic Review Source Type: research

Predicting patient-level new-onset atrial fibrillation from population-based nationwide electronic health records: protocol of FIND-AF for developing a precision medicine prediction model using artificial intelligence
Introduction Atrial fibrillation (AF) is a major cardiovascular health problem: it is common, chronic and incurs substantial healthcare expenditure because of stroke. Oral anticoagulation reduces the risk of thromboembolic stroke in those at higher risk; but for a number of patients, stroke is the first manifestation of undetected AF. There is a rationale for the early diagnosis of AF, before the first complication occurs, but population-based screening is not recommended. Previous prediction models have been limited by their data sources and methodologies. An accurate model that uses existing routinely collected data is n...
Source: BMJ Open - November 2, 2021 Category: General Medicine Authors: Nadarajah, R., Wu, J., Frangi, A. F., Hogg, D., Cowan, C., Gale, C. Tags: Open access, Cardiovascular medicine Source Type: research