The Future of Cardiac Rhythm Management: Emerging Technologies and Opportunities for Medical Device Clinical Trials

In a dimly lit hospital room, a heart monitor's screen displays vital signs, illuminating the surroundings.

Cardiovascular disease (CVD) is the leading cause of mortality and disability worldwide, leaving clinical research that supports cardiovascular risk reduction as a vital necessity. In 2020, approximately 697,000 people died in the U.S. from heart disease. By 2030, the Centers for Disease Control and Prevention (CDC) expects around 12.1 million to have atrial fibrillation (AFib) in the U.S. alone, leading to an increase in people needing cardiac rhythm management (CRM). As the need for CRM increases, so does the need for medical device clinical trials.

In this article, we explore the exciting advancements and opportunities in the field of medical device clinical trials, specifically focusing on CRM. We delve into the role of emerging technologies, highlighting specific areas of focus, including remote heart failure monitoring, patient perspectives, intervention advancements, clinical trial design, virtual care models, and patient populations.

What is Cardiac Rhythm Management?

Cardiac rhythm management (CRM) encompasses a range of medical devices and therapies designed to monitor, regulate, and restore the normal rhythm of the heart. The goal of CRM is to treat various cardiac arrhythmias and improve the overall function of the heart.

CRM devices are at the forefront of combating cardiovascular disease (CVD). With the rising prevalence of CVD and the increasing demand for effective treatments, the CRM device market is projected to reach remarkable heights in the coming years. As a result, there is a growing need for medical device clinical trials to support the development and evaluation of these emerging technologies.

A recent study projected that the medical device market, including cardiac rhythm management (CRM) devices, will reach US$964.9 billion by 2030. In addition to managing and monitoring cardiac issues, CRM devices have applications in repairing, restoring, and healing cardiac activities. To support the growing demand for medical device clinical trials, the medical device CRO market is projected to grow at a compound annual growth rate (CAGR) of 9.6% to exceed US$15.1 billion by 2030.

The global CRM device market in 2021 was valued at US$18.1 billion and is projected to grow at a CAGR of 6.5% from 2022 to 2030. Growth factors include the growing prevalence of various CVD and advancements in related tech and medical devices. Defibrillators held the largest revenue share (43.6%) of the CRM devices market in 2021 due to increasing adoption, primarily of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) and Transvenous Implantable Cardioverter Defibrillator (T-ICD). Companies are prioritizing the development of new medical devices based on existing pacemakers and ICD technologies.

Emerging Technologies in Medical Device Clinical Trials

On the evolving roles of digital health, big data, and AI in cardiovascular care, Jain (2021) of the American College of Cardiology highlighted technologies used to monitor health, prevent or diagnose disease, and deliver patient-centered care.

For example:

  • medical devices allow for real-time monitoring
  • mobile and web applications serve as the interface between the user and other technologies
  • health information technology (HIT), which includes electronic health records (EHR) and large data repositories, enables big data analysis
  • AI in cardiology refers to data extraction, diagnosis and classification of cardiac disease, and outcome prediction models
  • new clinical care models and decentralized clinical trials.

When working cohesively, these technologies can redefine how patients engage the healthcare system. In clinical research, Jain et al. (2021) highlights the need to build a field of evidence generation to test the effectiveness of emerging technologies like digital health and AI algorithms.

Emerging Technologies for Cardiac Rhythm Management (CRM)

As cardiac rhythm management (CRM) technologies continue to advance, new opportunities arise for improving patient care and enhancing clinical trials in the field. One area of significant development is remote heart failure (HF) monitoring, where implantable devices like implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices with defibrillators (CRT-D) have evolved to deliver real-time cardiac hemodynamics. The most efficacious has a pulmonary artery pressure sensor, which has been proven to be safe and demonstrated a reduction in HF hospitalizations.

These advancements include the incorporation of pulmonary artery pressure sensors, which have shown efficacy in reducing HF hospitalizations. Additionally, emerging technologies like implantable loop recorders enable remote monitoring of syncope and arrhythmias, offering valuable insights into patient selection, risk stratification, and outcomes after ICD placement. However, the impact of remote monitoring on clinical outcomes remains controversial, emphasizing the need for a thorough evaluation of the data generated by these systems.

Within clinical research, it is important to explore the implications of emerging technologies, patient perspectives, incremental advancements in interventions, clinical trial design, virtual care models, and considerations for diverse patient populations.

Patient perspective

Recognizing the importance of the patient perspective in the development of CRM technologies is crucial. Researchers are actively involving patients in the co-design and evaluation processes. A European consortium, who was developing an implantable monitoring device, co-designed a study with patient collaborators. The study was conducted to identify the main issues, from the patients’ perspective, related to the new cardiac implant. These types of studies contribute to the development of patient-centered clinical trials and shed light on social factors that affect the adoption of medical devices. Future medical device clinical trials may follow suit for more patient-centric clinical trials.

Evolution and incremental advancements of interventions

While remote monitoring of cardiac implantable electronic devices (CIED) receives priority recommendations for HF patient care, Kowal et al. (2023) highlights its limitation of poor patient adherence. The study found that a smartphone app communicating with CIED improved patient engagement and adherence and the accuracy of silent atrial and ventricular arrhythmias diagnosis. These findings provided new insights that can be further studied.

Clinical trial design

To complement randomized controlled trials (RCT), Zhao & Yao (2022) reviewed pragmatic clinical studies and discussed their importance in evidence-based practice for CVD. The development of pragmatic clinical studies is driven by the increased availability and quality of EHRs, and the authors conclude that these studies will continuously develop.

Graham et al. (2022) studied the application of computable phenotypes within a common data model (CDM) to identify HF patients for an implantable cardiac device registry. The authors found that the consistency between manually-collected registry data and CDM-based phenotypes for history of HF was high overall. They concluded that combining computable phenotypes with CDM-structured data is promising and could reduce repetitive work and unwanted variance. They acknowledged several study limitations which require further study.

Virtual care models

Mayfield et al. (2021) studied a novel, exclusively remote RCT with cardiac monitoring where all study activities were done remotely. This included the digital transmission of electrocardiographic (ECG) measurements and self-collected vital signs. The authors concluded that digital health technologies could be leveraged to conduct rigorous, safe, and exclusively remote clinical trials. Sponsors and CROs can explore opportunities to reimagine CRM clinical trials.

Kelly et al. (2020) assert that virtual follow-up is highly heterogeneous from who receives or is offered it; to who, when, and how it is delivered; and how data transmissions or alerts are managed. Therefore, improving and expanding virtual care across diverse populations and care settings requires understanding the comparative effectiveness, safety, and cost of virtual interventions for patients with CIEDs. Further, how patients or system factors influence outcomes needs to be studied.

Patient populations

Regarding real-world disparities in the virtual follow-up of CIEDs, Lehmann et al. (2023) studied if racial and socioeconomic disparities were present in CIED remote monitoring in a single center. The authors found significant disparities and called for further studies to examine health center- and patient-specific factors to overcome barriers and facilitate equal opportunities to benefit from remote monitoring. On access to telemedicine and digital tools, Vitolo et al. (2022) studied digital health literacy among frail and non-frail cardiology patients. The authors found that frailty strongly influenced digital skills, even though frail patients would benefit most from telemedicine.

Top CRO in Cardiology and Medical Device Research

Looking for a top CRO to support your next cardiology or medical device clinical trial? CROs like the Vial Cardiology CRO and Medical Device CRO play a crucial role in advancing treatments for cardiovascular disease. Vial uses data-driven approaches, innovative patient-centered trials, and transformative technologies to conduct cardiology clinical trials efficiently. Contact a Vial team member today to learn how we can provide faster, better, and cheaper trials.

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