Highlighting the Impacts of Cardiac Devices on Upper Limb Function
Hacettepe University is conducting a clinical trial examining upper extremity function in patients who have reduced ejection fraction heart failure and rely on cardiac implantable electronic devices (CIEDs). This observational study aims to provide insights valuable to clinical, regulatory, and quality assurance teams evaluating long-term outcomes in such patients. Recruitment is currently by invitation only as of November 29, 2025.
In this article:
- What is the focus of this study?
- Which patients are included?
- Why is this study important for stakeholders?
- Frequently Asked Questions
- Key Takeaways
- Disclaimer
What is the focus of this study?
Patients with reduced ejection fraction heart failure often depend on devices such as implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) to manage their conditions. While these devices are lifesaving, their impact on the daily functionality of patients, particularly relating to arm and shoulder function, is less well-documented.
This study seeks to address the gap by investigating the upper extremity function of individuals who have had CIEDs implanted. The research is designed to capture critical data on mobility impairments or limitations that may arise post-implantation.
Which patients are included?
This is an observational trial, meaning it does not involve new interventions. It specifically includes individuals diagnosed with reduced ejection fraction heart failure and equipped with either ICD or CRT devices. The scope of the study is confined to such patients and recruitment is being managed through invitations, ensuring the participant cohort closely matches the study objectives.
The focus on this patient group is critical since they face a unique intersection of challenges related to cardiac health and physical mobility. Understanding their functional outcomes can inform clinical guidelines and device design improvements.
Why is this study important for stakeholders?
The findings from this trial could have significant implications for clinical management, regulatory decision-making, and device performance evaluation. Regulators and manufacturers rely on real-world data to ensure that medical devices provide both safety and efficacy while maintaining patient quality of life.
Examining upper limb function in patients with cardiac devices may also lead to updates in post-market surveillance protocols. The data could highlight areas where additional support or rehabilitation is required for patients post-implantation. Quality assurance teams may benefit from a more comprehensive understanding of device impact beyond heart-specific benefits, enabling them to address secondary effects more effectively.
The outcomes could further contribute to refining physical therapy protocols or redesigning cardiac devices for enhanced compatibility with daily activities.
Frequently Asked Questions
- What type of study is this?
This is an observational, non-interventional study. - Is the study currently enrolling participants?
Yes, enrollment is open but limited to invited participants. - What conditions are being studied?
The study focuses on reduced ejection fraction heart failure in patients using ICD or CRT devices. - Who sponsors this research?
The study is sponsored by Hacettepe University.
Key Takeaways
This study focuses on better understanding the physical implications of ICD and CRT device implantation in heart failure patients. The results aim to enhance clinical care and provide regulatory insights. Stakeholders are encouraged to follow the progress for potential contributions to device improvements and rehabilitation protocols.
Disclaimer
This content is provided for informational purposes only and does not constitute legal or medical advice. Healthcare professionals should consult relevant guidelines and regulators for specific queries.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07253909?term=medical+device