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P-wave terminal force in lead V1 and atrial fibrillation burden in cryptogenic stroke with implantable loop recorders
AbstractImplantable loop recorders (ILRs) are useful for the detection of atrial fibrillation (AF) in patients with cryptogenic stroke (CS). P-wave terminal force in lead V1 (PTFV1) is associated with AF detection; however, data on the association between PTFV1 and AF detection using ILRs in patients with CS are limited. Consecutive patients with CS with implanted ILRs from September 2016 to September 2020 at eight hospitals in Japan were studied. PTFV1 was calculated by 12-lead ECG before ILRs implantation. An abnormal PTFV1 was defined as  ≥ 4.0 mV × ms. The AF burden was calculated as a proportion based on t...
Source: Journal of Thrombosis and Thrombolysis - May 2, 2023 Category: Hematology Source Type: research

Registry for Evaluating Healthy Life Expectancy and Long-Term Outcomes after Catheter Ablation of Atrial Fibrillation in the Very Elderly (REHEALTH AF) study: rationale and design of a prospective, multicentre, observational, comparative study
Introduction Data are lacking on the extent to which patients with non-valvular atrial fibrillation (AF) who are aged ≥80 years benefit from ablation treatment. The question pertains especially to patients’ postablation quality of life (QoL) and long-term clinical outcomes. Methods and analysis We are initiating a prospective, registry-based, multicentre observational study that will include patients aged ≥80 years with non-valvular AF who choose to undergo treatment by catheter ablation and, for comparison, such patients who do not choose to undergo ablation (either according to their physician’s advice...
Source: BMJ Open - February 15, 2023 Category: General Medicine Authors: Okumura, Y., Nagashima, K., Watanabe, R., Yokoyama, K., Kato, T., Fukaya, H., Hayashi, H., Nakahara, S., Shimizu, W., Iwasaki, Y.-k., Fujimoto, Y., Mukai, Y., Ejima, K., Otsuka, T., Suzuki, S., Murakami, M., Kimura, M., Harada, M., Koyama, J., Okamatsu, H Tags: Open access, Cardiovascular medicine Source Type: research

Effects of a Pharmacist-Led Educational Interventional Program on Electronic Monitoring-Assessed Adherence to Direct Oral Anticoagulants: A Randomized, Controlled Trial in Patients with Nonvalvular Atrial Fibrillation
In this study, the selection of DOACs was not randomized, and the lack of assessment of the association between adherence to DOACs and clinical outcomes was a limitation. Japan Registry of Clinical Trials (jRCT) indentifier: jRCTs031180142. (Clin Ther. 2022;44:XXX-XXX) © 2022 Elsevier Inc.PMID:36244853 | DOI:10.1016/j.clinthera.2022.09.011
Source: Clinical Therapeutics - October 16, 2022 Category: Drugs & Pharmacology Authors: Tsuyoshi Shiga Toshimi Kimura Noritoshi Fukushima Yuji Yoshiyama Kazunori Iwade Fumiaki Mori Yoichi Ajiro Shoji Haruta Yuichiro Yamada Emi Sawada Nobuhisa Hagiwara SMAAP-AF Investigators Source Type: research

Rationale and design of a prospective study evaluating population pharmacokinetics and pharmacodynamics of rivaroxaban in Chinese patients with non-valvular atrial fibrillation
Introduction Rivaroxaban is one of the most commonly used non-vitamin K antagonists for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Different individual exposures exist for Asian and non-Asian populations, and dose selection is different for Japanese and non-Japanese subjects. Few studies have investigated the pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in Chinese patients and provided a solid reference for dose selection and individualised therapy. Methods and analysis This is a single-centre prospective study. Rivaroxaban-treated Chinese NVAF patients will be recruited ...
Source: BMJ Open - June 3, 2022 Category: General Medicine Authors: Liu, X.-Q., Zhang, Y.-F., Ding, H.-Y., Yan, M.-M., Zhong, M.-K., Ma, C.-L. Tags: Open access, Pharmacology and therapeutics Source Type: research

FDA Approves Two New Indications for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, Dec. 20, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have...
Source: Johnson and Johnson - December 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenita...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Biotronik launches Itrevia MRI-safe quad CRT-D in Japan
Biotronik said today that it launched its Itrevia MRI-safe quad cardiac resynchronization therapy defibrillator in Japan, part of a Japanese rollout of new devices for 2015. The device is equipped with home monitoring connectivity, as well as compatibility with up to 1.5 tesla MRI machines, the German medical device giant said. “As a producer of superior medical technologies, it is imperative for us to have a presence in the world’s leading technologies market. It also makes sense that the world’s biggest producer of ProMRI technology should have a strong presence in the country where MRI scanning is the...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Surgical Biotronik Source Type: news