Arrhythmia Core Lab

Arrhythmia Core Lab

At the DCRI, the Arrhythmia Core Laboratory (ACL) is dedicated to providing high-quality evaluation, adjudication, and validation of electrocardiographic and electrogram review. Led by Jonathan Piccini, MD, MHS, and Associate Director Sean Pokorney, MD, MBA, the ACL has extensive experience in heart rhythm monitoring, 12-lead electrocardiogram and device-based electrogram event adjudication, arrhythmia science, clinical trials design and execution, and outcomes research.

Efficient. Innovative. Reliable.

Our adjudicators comprise the largest HRS board-certified faculty of electrophysiologists across the globe, and we have enrolled more patients in heart rhythm-related trials than any other academic medical center. Our thought leadership, experience, and collaboration with the other trial support units at the DCRI set us apart.

DCRI’s ACL is an integral part of the DCRI Clinical Events Classification (CEC) group. The CEC group is committed to providing the highest-quality adjudicated endpoint data with scientific rigor, efficiency, and innovation by coordinating and conducting systematic, comprehensive, unbiased, blinded, and independent clinical events adjudication. With more than 170,000 projects adjudicated, more than 100 trials completed, more than 50 trials ongoing, and more than 32,000 reviews per year, CEC brings discipline to every project—from start to finish.

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  • Our Approach
  • Our Services
  • The Future for Core Labs

Our Capabilities and Expertise

The ACL provides heart rhythm evaluation and adjudication across several modalities and multiple study designs and settings. Our services include:

  • Evaluation and adjudication of 12-lead electrocardiograms
  • Evaluation and adjudication of ambulatory monitoring tracings and results
  • Evaluation and adjudication of device-based diagnostics and electrograms (including but not limited to pacemaker, implantable cardioverter defibrillator, and cardiac resynchronization therapy recordings)
  • Design and implementation of core laboratory protocols, study manuals, and procedures
  • Quality assurance evaluations and validation for the blinded adjudication process
  • Publication and dissemination of study results
  • Pre-clinical, phase I, II, and III clinical trials, post-marketing, and observational studies
  • Clinical trial design, support, and execution

Select DCRI Electrophysiology Clinical Trials and Core Lab Projects

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In additional to our services, our IBM Clinical Development Endpoint Adjudication Module (EAM)™ allows reviewers to adjudicate electronically with an Internet connection; track the workflow process, providing a full audit trail (21 CFR part 11-compliant); produce reports from executive summary to detailed information; and provide electronic dossiers.

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Our History

The DCRI and Duke ACL have participated in numerous studies of heart rhythm therapies over the past 15–20 years. Notable projects include the Mode Selection Trial in Sinus Node Dysfunction (MOST) and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). The ACL also served as the core laboratory for the first study of noninvasive ventilation in patients with heart failure and sleep apnea (CAT-HF) and the first pharmacogenetic-guided trial of beta-blocker therapy for the prevention of recurrent AF in patients with heart failure (GENETIC AF).

Leadership

With extensive clinical and operational experience, DCRI’s ACL leadership is dedicated to advancing clinical research, establishing best practices, and sharing knowledge to improve patient care.

Jonathan P. Piccini, MD, MHS, FHRS

Jon is the director of the Arrhythmia Core Laboratory. He is a clinical cardiac electrophysiologist and associate professor of medicine at Duke University Medical Center and the Duke Clinical Research Institute. Dr. Piccini is also the director of the Duke Center for Atrial Fibrillation and the Duke Center for Arrhythmia Research and Treatment Innovation at Duke University. Dr. Piccini has more than 250 publications in the field of heart rhythm medicine. Contact: jonathan.piccini@duke.edu

Sean D. Pokorney, MD, MBA

Sean is the associate director of the Arrhythmia Core Laboratory. He is a clinical cardiac electrophysiologist and assistant professor of medicine at Duke University Medical Center and the Duke Clinical Research Institute. Dr. Pokorney has published extensive research in heart rhythm medicine in several several notable publications including JAMA, Lancet, Circulation, Journal of the American College of Cardiology, Heart Rhythm, JACC Electrophysiology, and Circulation Arrhythmia and Electrophysiology. Contact: sean.pokorney@duke.edu

Jeff Kanters, RN, RQAP-GCP
Jeff is the project leader for the Duke Arrhythmia Core Laboratory. With over 25 years in clinical research trial coordination, monitoring, project and program management, his expertise encompasses all phases of trial conduct and execution in both pharmaceutical and medical device industries as well as government trials. Jeff’s particular focus is in clinical operations and imaging core lab project management. He also has national certifications in regulatory affairs, and quality assurance, and is credentialed as a Registered Quality Assurance Professional in Good Clinical Practice.  Contact: jeff.kanters@duke.edu.