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Search / Trial NCT06930833

FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study

Launched by CORSANO HEALTH B.V. · Apr 9, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Frailty 6 Minute Walking Test G8 Score Wristband Wearable Remote Monitoring Cardiac Surgical Interventions

ClinConnect Summary

The FRAILTY-CARDIOWATCH study is looking at how well a new wrist-worn device called the Corsano CardioWatch 287-2 can help identify frailty in older patients. Frailty means having less strength and endurance, which can make it harder for older adults to stay healthy or recover from illnesses. This study will focus on patients aged 70 and older who are scheduled for heart-related procedures, like valve replacements or pacemaker insertions. The goal is to create a tool that can accurately assess frailty using the CardioWatch, and researchers will compare its results with traditional tests that measure frailty.

If you or a loved one is over 70 years old and is set to undergo one of the specified heart procedures, you might be eligible to participate. Participants will wear the CardioWatch for six days and complete some simple tests to help the researchers gather important information. This study could lead to better ways to monitor frailty in older patients using wearable technology, making it easier for healthcare providers to offer the right support. Remember, the study is not recruiting participants yet, but it represents a promising step towards improving care for older adults with heart conditions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • ≥ 70 years old
  • Be able to provide consent
  • * Be scheduled to undergo one of the following procedures:
  • Aortic valve replacement
  • Mitral valve repair with MitraClip
  • Implantation of a pacemaker
  • Percutaneous coronary intervention (PCI)
  • Exclusion Criteria:
  • Unable to wear the Corsano CardioWatch 287-2 due to reasons such as allergic reactions, wounds, amputations etc.;
  • Unable or unwilling to sign informed consent;
  • Significant mental or cognitive impairment;
  • Cardiovascular disease where heart rate is not measurable (e.g. LVAD)

About Corsano Health B.V.

Corsano Health B.V. is a pioneering clinical trial sponsor dedicated to advancing healthcare through innovative research and development. Specializing in the design and execution of clinical studies, Corsano Health leverages cutting-edge technologies and methodologies to enhance patient outcomes and drive efficiencies in the clinical trial process. With a commitment to ethical practices and regulatory compliance, the organization collaborates with various stakeholders, including healthcare professionals, research institutions, and biopharmaceutical companies, to bring transformative therapies to market. Corsano Health B.V. is at the forefront of improving clinical trial strategies, ultimately contributing to the evolution of personalized medicine.

Locations

Delft, Zuid Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Mariska van Vliet, MD, PhD

Principal Investigator

Reinier de Graaf Groep

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported