TruVue Wireless ECG Monitoring in Clinical Trials

In 2010, Biomedical Systems introduced the TruVue® Wireless Ambulatory ECG Monitoring System for the diagnosis and management of complex cardiac arrhythmia. TruVue offers the advantages of both a Holter and Cardiac Event monitor in one device. The patented technology employs cellular communication to transmit recordings of every heartbeat to Biomedical Systems' secure servers. The system's algorithms analyze the incoming data for changes in morphology, rate or rhythm, in addition to patient-triggered alerts when symptoms are experienced. Certified cardiac technicians validate the findings, post reports in real-time and alert physicians based on cardiac events or notification criteria. At any time, physicians can access information online, including any portion of the recorded ECG monitoring and trend reports detailing 24-hour heart-rate and rhythm abnormalities, including atrial fibrillation.

Currently, pharmaceutical and medical device companies are employing TruVue to assess the cardiovascular safety and efficacy associated with new drugs and devices. In pharmaceutical clinical trials, TruVue's heart monitoring capabilities support the efficient and accurate capture of valid data during Phase 1 to IV clinical studies or in post-marketing surveys. When employed in clinical trials, TruVue is supported by around-the-clock patient support and services provided by professional, courteous Biomedical Systems staff. TruVue has received both its 510(k) clearance from the U.S. Food and Drug Administration and its CE Mark for international sales. Biomedical Systems' Cardiology Division has employed TruVue since 2010, conducting thousands of ECG wireless telemetry procedures.

Thorough QT Studies/Intensive Studies in Clinical Trials

Addressing Cardiac Safety Concerns for Drug Induced Prolonged QT

The FDA primarily calls for the withdrawal of a drug from the market, limits a drug’s indications, or denies pharmaceutical companies approval to market a drug due to cardiac safety concerns. A major issue of concern is drug induced delay in cardiac repolarization. As a result of such concerns, the FDA with international regulatory organizations has requested pharmaceutical companies and biotech companies conduct more intensive testing for cardiac safety concerns utilizing protocol designs known as Thorough QT studies or Intensive QT studies.

Thorough QT/Intensive QT Studies Protocol Design

In 2005, the FDA released guidance for the clinical trial industry in E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. The E14 document indicates a need for additional cardiac safety testing when a positive signal for QT prolongation is found in pre-clinical development of a compound. Thorough QT/Intensive QT studies use precise methodologies to detect and evaluate the QT interval prolongation of small magnitudes to better assure a new drug’s cardiac safety.

E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs recommendations:

FDA Warehouse and ECG Submissions

Based on recommendations from The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs concept paper released for discussion by the FDA in 2003, annotated ECG waveform data for studies that definitively address the effects of a drug on ventricular repolarization is critical. As such, the FDA entered into a Cooperative Research and Development Agreement with Mortara Instruments to design a repository to house and manage the massive number of ECGs that would be required for these trials. A standardized reporting format was needed to ensure that the data was consistent between sponsors and trials which led to the adoption of the HL7 and XML formats, the language for all ECGs transmitted to the warehouse. As a leader in the cardiac safety and efficacy clinical trial industry, Biomedical Systems has been submitting data to the FDA ECG Warehouse on behalf of sponsors since 2004 and has continued to submit data to the warehouse regularly ever since its public rollout in 2005.

Cardiac Event Monitoring in Clinical Trials

Introduced in the late 1980s, Cardiac Event Monitoring (CEM), also known as Transtelephonic Arrhythmia Monitoring (TTM) involves patient utilization of a cardiac monitor which typically records a single channel of ECG using two electrodes for up to 30 days. The ECG recording is intermittent, taken in 1 to 5 minute samples. Recorded ECG data is transmitted via telephone to a receiving center where rhythm strips are reviewed by certified cardiac technicians. Cardiac Event Monitoring requires 24/7 receiving of ECG transmissions and provides no quantification of abnormalities; however, CEM does provide a longer monitoring period improving the ability to diagnose intermittent symptoms in patients and rule-in or rule-out arrhythmia as the cause of patient symptoms.

For 25 years, Biomedical Systems has provided protocol development, standardized equipment, study and data management, and technical support services for cardiac event monitoring used in clinical trials. We continue to meet our clients’ needs by offering a variety of equipment options including non-looping, looping, and looping with auto-trigger devices. In order to make equipment recommendations that ensure the appropriate data outcomes per protocol requirements, Biomedical Systems provides our clients with consultation services. Regardless of the equipment chosen, all of our clients enjoy friendly, professional customer service from fully certified cardiac technicians as well as technical support 24 hours a day, 7 days a week, and 365 days a year from any one of our four strategically located international offices.