2017
Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials An Academic Research Consortium Initiative
Lansky AJ, Messé SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials An Academic Research Consortium Initiative. Journal Of The American College Of Cardiology 2017, 69: 679-691. PMID: 28183511, DOI: 10.1016/j.jacc.2016.11.045.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesClinical Trials as TopicEndpoint DeterminationHumansNervous System DiseasesResearch DesignConceptsCardiovascular proceduresClinical trialsNeurological endpointsAcademic Research ConsortiumBenefit-risk assessmentAdjunctive pharmacologyNeurological complicationsNeurological outcomePreventive therapyClinical effectsNeurovascular injuryNeurological injuryNeurological riskEndpoint definitionsCardiovascular interventionsAscertainment methodsTherapyInjuryResearch ConsortiumRiskTrialsEndpointInherent risksSuch proceduresComplications
2012
2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow-up, Definitions, Endpoints, and Research Trial Design
Calkins H, Hindricks G, Cappato R, Kim Y, Saad E, Aguinaga L, Akar J, Badhwar V, Brugada J, Camm J, Chen P, Chen S, Chung M, Nielsen J, Curtis A, Davies D, Day J, d’Avila A, de Groot N, Di Biase L, Duytschaever M, Edgerton J, Ellenbogen K, Ellinor P, Ernst S, Fenelon G, Gerstenfeld E, Haines D, Haissaguerre M, Helm R, Hylek E, Jackman W, Jalife J, Kalman J, Kautzner J, Kottkamp H, Kuck K, Kumagai K, Lee R, Lewalter T, Lindsay B, Macle L, Mansour M, Marchlinski F, Michaud G, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds M, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao H, Verma A, Wilber D, Yamane T. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow-up, Definitions, Endpoints, and Research Trial Design. Heart Rhythm 2012, 9: 632-696.e21. PMID: 22386883, PMCID: PMC5846182, DOI: 10.1016/j.hrthm.2011.12.016.Peer-Reviewed Original Research
2009
Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort The IMPACT study
Ip J, Waldo AL, Lip GY, Rothwell PM, Martin DT, Bersohn MM, Choucair WK, Akar JG, Wathen MS, Rohani P, Halperin JL, Investigators F. Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort The IMPACT study. American Heart Journal 2009, 158: 364-370.e1. PMID: 19699858, DOI: 10.1016/j.ahj.2009.07.002.Peer-Reviewed Original ResearchConceptsAtrial high-rate episodesRisk of strokeAnticoagulant therapyAtrial fibrillationAtrial flutterCardiac resynchronization therapy-defibrillator deviceConventional clinical managementRemote rhythm monitoringStudies of anticoagulationRate of strokeOral anticoagulant therapyHigh-rate episodesAdditional risk factorsCRT-D devicesStroke risk stratificationCommon cardiac arrhythmiaAHRE burdenElectrocardiographic documentationMajor bleedingSystemic embolismProphylactic therapyClinical characteristicsStroke riskAnticoagulation decisionsClinical features