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. Founded by Jonathan Piccini, MD, MHS, and led by 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.

The DCRI ACL has the largest group of HRS board-certified clinical cardiac electrophysiology adjudicators across the globe. At the DCRI, we have enrolled and randomized 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 over 250,000 patients adjudicated, more than 250 trials completed, 30+ active trials, and 500,000+ adjudications completed, CEC brings discipline to every project—from start to finish.

DOWNLOAD OUR ACL FACT SHEET

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

In addition, our Electronic Adjudication System technology 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.

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.

SEAN D. POKORNEY, MD, MBA

Sean is the 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

JONATHAN P. PICCINI, MD, MHS, FHRS

Jon is the founder of DCRI’s Arrhythmia Core Laboratory. He is a clinical cardiac electrophysiologist and associate professor of medicine at Duke University Medical Center and the DCRI. Dr. Piccini is also the Director of Cardiac Electrophysiology at Duke University. His focus is on the care of patients with atrial fibrillation and complex arrhythmias. His research interests include the conduct of clinical trials and the assessment of innovative cardiovascular therapeutics for the care of patients with heart rhythm disorders. Dr. Piccini has over 400 publications in the field of heart rhythm medicine. Contact: jonathan.piccini@duke.edu.

CASEY NORRIS, MS

Casey Norris, MS, is a Senior Project Leader with DCRI’s Arrhythmia Core Laboratory and Clinical Events Classification teams. He is an experienced project leader with over 12 years of clinical trial operations experience. His knowledge extends to clinical trial management; case processing, site management, and project management for both global and small-scale clinical trials within clinical event classification and core lab settings; staff development and mentorship; ECG instruction; and clinical exercise physiology. His current focus is in core lab and clinical event classification project management. Casey is a clinical exercise physiologist by trade.

Trial — Intervention

MOST* — DDDR vs. VVIR in Sinus Dysfunction
SCD-HeFT* — Primary prevention ICD
HAT* — Home AED after MI
ROCKET* — Rivaroxoban vs. warfarin
ARISTOTLE* — Apixaban vs. warfarin
CAT HF Arrhythmia Study* — OSA in HF patients with devices
CABANA* — AF ablation vs. medical Rx
GENETIC AF* — Genetic-guided BB dosing in AF
APPRAISE ATP ICD Core — Largest randomized ICD trial: ATP vs. no ATP
Phase 1b HF IND dose-response study — Safety/tolerability in HF patients with ICD/CRT
Post-market, observational study — ICM remote programming efficacy
Novel Gene Therapy for Fabry Dz — Arrythmia monitoring for safety/tolerability

*Trial completed