Abbonarsi

Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: A Cardiac Safety Research Consortium “Incubator” Think Tank - 05/08/11

Doi : 10.1016/j.ahj.2010.06.044 
Sana M. Al-Khatib, MD, MHS a, , p , Hugh Calkins, MD b, p, Benjamin C. Eloff, MD c, p, Peter Kowey, MD d, p, Stephen C. Hammill, MD e, p, Kenneth A. Ellenbogen, MD f, p, Danica Marinac-Dabic, MD, PhD c, p, Albert L. Waldo, MD g, p, Ralph G. Brindis, MD, MPH h, p, David J. Wilbur, MD i, Warren M. Jackman, MD j, p, Marcia S. Yaross, PhD k, p, Andrea M. Russo, MD l, p, Eric Prystowsky, MD m, Paul D. Varosy, MD n, p, Thomas Gross, MD, MPH c, p, Ellen Pinnow, MS c, p, Mintu P. Turakhia, MD, MAS o, p, Mitchell W. Krucoff, MD a, p
a Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 
b Johns Hopkins University, Baltimore, MD 
c US Food and Drug Administration, Silver Spring, MD 
d Main Line Health Heart Center, Philadelphia, PA 
e Mayo Clinic, Rochester, MN 
f Virginia Commonwealth University School of Medicine, Richmond, VA 
g Case Western Reserve University, Cleveland, OH 
h American College of Cardiology, Washington, DC and Oakland Kaiser Permanente, Oakland, CA 
i Loyola University Medical Center, Chicago, IL 
j University of Oklahoma Health Sciences Center, Oklahoma City, OK 
k Biosense Webster, Diamond Bar, CA 
l Robert Wood Johnson Medical School/Cooper University Hospital, Camden, NJ 
m The Care Group, Indianapolis, IN 
n Denver Veteran's Affairs Medical Center and University of Colorado, Denver, CO 
o Palo Alto VA Health Care System, Palo Alto, CA and Stanford University, Stanford, CA 

Reprint requests: Sana M. Al-Khatib, MD, MHS, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.

Riassunto

Although several randomized clinical trials have demonstrated the safety and efficacy of catheter ablation of atrial fibrillation (AF) in experienced centers, the outcomes of this procedure in routine clinical practice and in patients with persistent and long-standing persistent AF remain uncertain. Brisk adoption of this therapy by physicians with diverse training and experience highlights potential concerns regarding the safety and effectiveness of this procedure. Some of these concerns could be addressed by a national registry of AF ablation procedures such as the Safety of Atrial Fibrillation Ablation Registry Initiative that was initially proposed at a Cardiac Safety Research Consortium Think Tank meeting in April 2009. In January 2010, the Cardiac Safety Research Consortium, in collaboration with the Duke Clinical Research Institute, the US Food and Drug Administration, the American College of Cardiology, and the Heart Rhythm Society, held a follow-up meeting of experts in the field to review the construct and progress to date. Other participants included the National Heart, Lung, and Blood Institute; the Centers for Medicare and Medicaid Services; the Agency for Healthcare Research and Quality; the AdvaMed AF working group; and additional industry representatives. This article summarizes the discussions that occurred at the meeting of the state of the Safety of Atrial Fibrillation Ablation Registry Initiative, the identification of a clear pathway for its implementation, and the exploration of solutions to potential issues in the execution of this registry.

Il testo completo di questo articolo è disponibile in PDF.

Mappa


 An educational collaboration among the CSRC, DCR, ACC, HRS, AdvaMed, and US FDA.
 This conference was funded by the CSRC, DCRI, ACC, HRS; registration fees and in-kind support from the FDA and AdvaMed.


© 2010  Mosby, Inc. Tutti i diritti riservati.
Aggiungere alla mia biblioteca Togliere dalla mia biblioteca Stampare
Esportazione

    Citazioni Export

  • File

  • Contenuto

Vol 160 - N° 4

P. 619 - Ottobre 2010 Ritorno al numero
Articolo precedente Articolo precedente
  • Addressing disparities in sudden cardiac arrest care and the underutilization of effective therapies
  • Melissa H. Kong, Eric D. Peterson, Gregg C. Fonarow, Gillian D. Sanders, Clyde W. Yancy, Andrea M. Russo, Anne B. Curtis, Samuel F. Sears, Kevin L. Thomas, Susan Campbell, Mark D. Carlson, Chris Chiames, Nakela L. Cook, David L. Hayes, Michelle LaRue, Adrian F. Hernandez, Edward L. Lyons, Sana M. Al-Khatib
| Articolo seguente Articolo seguente
  • Electrocardiographic assessment for therapeutic proteins—scientific discussion
  • Ignacio Rodriguez, Andrew Erdman, Desmond Padhi, Christine E. Garnett, Hong Zhao, Shari L. Targum, Suchitra Balakrishnan, Colette Strnadova, Norman Viner, Mary Jane Geiger, Christopher Newton-Cheh, Jeffrey Litwin, Michael K. Pugsley, Philip T. Sager, Mitchell W. Krucoff, John K. Finkle

Benvenuto su EM|consulte, il riferimento dei professionisti della salute.
L'accesso al testo integrale di questo articolo richiede un abbonamento.

Già abbonato a @@106933@@ rivista ?

Il mio account


Dichiarazione CNIL

EM-CONSULTE.COM è registrato presso la CNIL, dichiarazione n. 1286925.

Ai sensi della legge n. 78-17 del 6 gennaio 1978 sull'informatica, sui file e sulle libertà, Lei puo' esercitare i diritti di opposizione (art.26 della legge), di accesso (art.34 a 38 Legge), e di rettifica (art.36 della legge) per i dati che La riguardano. Lei puo' cosi chiedere che siano rettificati, compeltati, chiariti, aggiornati o cancellati i suoi dati personali inesati, incompleti, equivoci, obsoleti o la cui raccolta o di uso o di conservazione sono vietati.
Le informazioni relative ai visitatori del nostro sito, compresa la loro identità, sono confidenziali.
Il responsabile del sito si impegna sull'onore a rispettare le condizioni legali di confidenzialità applicabili in Francia e a non divulgare tali informazioni a terzi.


Tutto il contenuto di questo sito: Copyright © 2025 Elsevier, i suoi licenziatari e contributori. Tutti i diritti sono riservati. Inclusi diritti per estrazione di testo e di dati, addestramento dell’intelligenza artificiale, e tecnologie simili. Per tutto il contenuto ‘open access’ sono applicati i termini della licenza Creative Commons.