Dataset Information

Study Design of the Nationwide Japanese Lead Extraction (J-LEX) Registry: Protocol for a Prospective, Multicenter, Open Registry.

ABSTRACT: Background:Transvenous lead extractions (TLEs) in Japan have grown to become the standard therapy since the approval of the laser extraction system in 2008. However, little is known about the current indications, methods, success rate, and acute complications in the real-world setting. Methods:The Japanese Lead EXtraction (J-LEX) registry is a nationwide, multicenter, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center. This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system. The acute success rate at discharge and complications associated with TLEs will be collected in all cases. Based on the provided information, the annual incidence and predictive factors for the outcomes will be investigated by the Event Assessment Committee (EAC). This registry started in July 2018 and the number of participating medical institutions will be more than 50 hospitals and the target number of procedures will be 500-1000 per year. We will also compare the results with other registries in foreign countries. Result:The results of this study are currently under investigation. Conclusion:The J-LEX registry will provide real-world data regarding the results and complications of TLEs for the various types of indications, methods, and performing hospitals in Japan.

SUBMITTER: Shoda M

PROVIDER: S-EPMC7532273 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Study Design of the Nationwide Japanese Lead Extraction (J-LEX) Registry: Protocol for a Prospective, Multicenter, Open Registry.

Shoda Morio M Kusano Kengo K Goya Masahiko M Nishii Nobuhiro N Imai Katsuhiko K Okamoto Yoji Y Takegami Misa M Nakao Yoko M YM Miyamoto Yoshihiro Y Nogami Akihiko A

Journal of arrhythmia 20200710 5

<h4>Background</h4>Transvenous lead extractions (TLEs) in Japan have grown to become the standard therapy since the approval of the laser extraction system in 2008. However, little is known about the current indications, methods, success rate, and acute complications in the real-world setting.<h4>Methods</h4>The Japanese Lead EXtraction (J-LEX) registry is a nationwide, multicenter, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National C ...[more]

PMID: 33024462

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Project description:BACKGROUND:Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited. OBJECTIVE:The aim of this study is to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial. METHODS:A total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective of describing the epidemiological pattern of AF. Patients will be officially enrolled in the National Tunisian Registry of Atrial Fibrillation (NATURE-AF) only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points. RESULTS:Results will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients. CONCLUSIONS:This study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. TRIAL REGISTRATION:ClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX). REGISTERED REPORT IDENTIFIER:RR1-10.2196/8523.

Dataset Information

Study Design of the Nationwide Japanese Lead Extraction (J-LEX) Registry: Protocol for a Prospective, Multicenter, Open Registry.

Publications

Study Design of the Nationwide Japanese Lead Extraction (J-LEX) Registry: Protocol for a Prospective, Multicenter, Open Registry.

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