ECG Core Laboratory
Clinical Cardiovascular Research Center
Precision in Every Beat, Excellence in Every Analysis.
The Cardiovascular & ECG Core Laboratory is part of the Clinical Cardiovascular Research Center, it has been at the forefront of cardiac safety and ECG analytics for over 40 years, providing top-of-the-line expertise in electrocardiographic data analysis. With decades of experience, the lab has developed and implemented state-of-the-art methodologies to ensure accurate, reliable, and high-quality ECG assessments for clinical trials, pharmaceutical research, and medical device validation. Our team of experts leverages cutting-edge technology and stringent quality control processes to support advancements in cardiac safety, drug development, and digital health innovations.
On-going studies
Advancing Clinical Science to Transform Medicine
ASSERT-AF
Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients.
HEROIC-PKP2
Pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease.
RIDGE-1 Phase 1b
Evaluating TN-401 is an AAV9-based PKP2 gene therapy designed to deliver functional copies of PKP2 directly to cardiomyocytes with a one-time IV dose.
DISCO: Tympanic Thermometer Study
The goal of this study is to collect febrile, healthy, and in some instances cold temperature data from human subjects ranging from newborns to geriatrics. This data will be used to develop a new thermometer.
HIS-CRT: His-Bundle Corrective Pacing in Heart Failure
A reandomized clinical trial to prospectively evaluate the efficacy and the mechanism of benefit of His-CRT vs. BIV-CRT.
SNAPSHOT-PKP2
Evaluating PKP2-ACM disease progression up to two years retrospectively and over twelve months prospectively, in up to 20 patients in the U.S.
ERADICATE-AF
To determine whether renal denervation when added to pulmonary vein isolation enhances long-term antiarrhythmic efficacy.
ICM-REDUCE-AF
Evaluating if the early intervention following percutaneous catheter ablation based on personalized ICM data could prevent the substrate progression that promotes the onset and maintenance of atrial arrhythmias.
Investigational gene therapy for treating catecholaminergic Polymorphic Ventricular Tachycardia (CPVT).
We have been proudly serving the field of ECG analysis and cardiac safety for over 35 years, delivering expertise and innovation.
1
ECG Analysis & Cardiac Safety Services
✔ Team of clinical cardiologists who are readily available to provide expert oversight and consultation as needed.
✔ Standard & Advanced ECG Analysis Comprehensive interpretation of 12-lead, Holter ECGs, and long-term ECG patch data.
✔ QT/QTc Interval Assessments – Thorough evaluation of cardiac repolarization for drug safety studies inlcuding QTcI and HR bin analsyis.
✔ Beat-to-Beat Variability Analysis – Detailed heart rate variability (HRV) and arrhythmia analysis.
✔ Morphological ECG Analysis – Detection of subtle waveform abnormalities.
✔ ECG Data Cleaning & Processing – Ensuring high-quality recordings.
✔ Review of Loop recorders and ICD/CRT device reports.
2
Custom ECG Research & Innovation
✔ Pharmaceutical & Medical Device Testing – ECG validation for novel drugs and cardiac devices.
✔ Machine Learning & AI Applications – Advanced ECG-based predictive modeling.
✔ Custom Signal Processing Pipelines – Tailored solutions for unique ECG research needs.
✔ ECG database and algorithm validation on historical data: telemetric & Holter ECG warehouse
✔ Access to high quality ECG recording devices for your clinical trials and associated FDA-cleared software technologies.
✔ eCOA clinical trials.
3
Wearable & Remote ECG Monitoring
✔ ECG Patch & Wearable Device Integration – Data processing for continuous ambulatory ECG monitoring.
✔ Signal Processing & Algorithm Development – AI-based detection and classification of ECG events.
✔ Telemedicine & Digital Health Solutions – Remote monitoring support for clinical applications.
✔ Combined the ECGs with PPG- and blood pressure data analysis.