2017
Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials
Lansky AJ, Messé SR, Brickman AM, Dwyer M, van der Worp H, 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 C, 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. European Heart Journal 2017, 39: 1687-1697. PMID: 28171522, PMCID: PMC6251670, DOI: 10.1093/eurheartj/ehx037.Peer-Reviewed Original ResearchConceptsCardiovascular proceduresClinical trialsNeurological endpointsAcademic Research ConsortiumBenefit-risk assessmentAdjunctive pharmacologyNeurological complicationsNeurological outcomePreventive therapyClinical effectsNeurovascular injuryNeurological injuryNeurological riskEndpoint definitionsCardiovascular interventionsAscertainment methodsTherapyInjuryResearch ConsortiumRiskTrialsEndpointInherent risksSuch proceduresComplicationsProposed 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 ResearchConceptsCardiovascular 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