New Opportunities for Understanding Cardioneuroablation Benefits
On September 29, 2025, the POLish Registry of CArdioneuroablation and CArdioneuromodulation commenced recruiting participants for its clinical study, offering fresh insights into autonomic and cardiovascular disorders through therapeutic innovation. Sponsored by SABAMED Medical Center Ltd., this initiative provides clinical, quality, and regulatory teams a pivotal chance to study state-of-the-art interventions aimed at autonomic dysfunction management.
Clinicians and healthcare stakeholders, particularly those focused on innovative medical devices and therapeutic interventions, can explore treatment options and contribute to ongoing validation processes key to regulatory confidence.
In this article:
What conditions are being studied?
The registry aims to evaluate a range of complex cardiovascular and autonomic disorders. These include:
- Vasovagal Syndrome (VVS)
- Cardioinhibitory Carotid Sinus Syndrome (CSS)
- Symptomatic Sinus Bradycardia (SB)
- Atrioventricular Block (AV)
- Postural Orthostatic Tachycardia Syndrome (POTS)
- Orthostatic Hypotension
- Inappropriate Sinus Tachycardia Syndrome (IST)
- Vasospastic Angina
- Microvascular Angina
- Autonomic Dysfunction and Diseases
This expansive scope positions the registry as a cornerstone for understanding targeted medical device interventions.
What interventions are involved?
Participants undergoing treatment will benefit from a range of medical device and therapeutic procedures, such as:
- Cardioneuroablation: A procedure targeting neurocardiac signals to assist in managing arrhythmias and bradycardia.
- Sinoatrial Node sparing hybrid ablation: Combining minimally invasive techniques for enhanced safety profiles.
- Cardiac sympathetic denervation: Modulation of sympathetic outflow to mitigate autonomic dysfunction.
- Transcutaneous Vagus Nerve Stimulation (tVNS): A non-invasive device offering neuromodulation benefits.
Advanced behavioral and rehabilitation programs such as the Hybrid Cardiac Rehabilitation Program complement device-based therapies, emphasizing patient well-being.
Who should care and why?
Medical Device Developers: The registry provides real-world evidence crucial for conformity assessment under MDR Annex XIV and FDA clinical guidelines. Stakeholders can access performance data beneficial for regulatory submissions.
Regulatory Professionals: Evidence sourced from this study strengthens post-market surveillance, boosts risk-benefit measurements, and aids global compliance initiatives.
Healthcare Providers: Physicians acquire firsthand insights into novel therapeutic pathways, expanding treatment possibilities for patients with autonomic and cardiovascular disorders.
Patients: Enrollees in the study can explore cutting-edge treatments offering improved outcomes for conditions frequently deemed challenging to manage.
FAQ
1. What is the purpose of the registry?
The registry investigates advanced medical device therapies for managing complex autonomic and cardiovascular disorders.
2. Who sponsors the study?
The SABAMED Medical Center Ltd. sponsors the research and recruitment effort.
3. Where can I learn more or participate?
The full details can be accessed on the official ClinicalTrials.gov study page.
Conclusion
The POLish Registry of CArdioneuroablation and CArdioneuromodulation offers robust learning avenues for regulatory affairs, medical device innovation, and healthcare advancement. As recruiting begins, stakeholders from various fields can leverage the registry’s findings to refine interventions, improve regulatory engagement, and enhance patient care.
Disclaimer
This article is designed for professional audiences. It is not legal advice and should not substitute expert consultancy aligned with your clinical, quality, or regulatory needs.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07196397?term=medical+device