{"type":"trials","record":{"id":35367,"source_id":"clinicaltrials-gov","external_id":"NCT06930833","title":"FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study","brief_summary":"The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients. Frailty is a condition often seen in older adults, characterized by decreased strength, endurance, and overall health, which can make individuals more vulnerable to illness or injury. The goal of this study is to develop an algorithm that can accurately assess frailty using the device. In phase 1 of the study, data will be collected from patients aged 70 or older who are scheduled for heart-related procedures, such as valve replacements or pacemaker implantation. The study aims to compare the frailty classifications of the CardioWatch with two established methods: the Geriatric 8 (G8) questionnaire and the FRAIL scale. It will also compare the CardioWatch with the 6-minute walk test. Patients will wear the CardioWatch for six days-three days before their procedure and three days after-and complete the G8, FRAIL, and 6-minute walk tests. The collected data will help develop and train the frailty classification algorithm. The main focus is to evaluate how well the frailty classifications from the CardioWatch match those from the other tests. This research could potentially lead to a more accurate and continuous way to monitor frailty in patients using wearable technology.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"Corsano Health B.V.","enrollment":20,"countries":["Netherlands"],"start_date":"2025-05-01","completion_date":"2026-10-01","last_update_date":"2025-04-20","source_url":"https://clinicaltrials.gov/study/NCT06930833","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":"FRAILTY-CW2","age_range":"70 Years","comparator":null,"organization":"Corsano Health B.V.","interventions":["Corsano CardioWatch 287-2"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Frailty score agreement between Geriatric-8 questionnaire and CardioWatch 287-2 — From start to end of first CardioWatc…","Frailty score agreement between FRAIL questionnaire and CardioWatch 287-2 — From start to end of first CardioWatch 287-…","Frailty score agreement between 6-minute walking test and CardioWatch 287-2 — From start to end of first CardioWatch 28…"],"design_description":null,"source_has_results":false},"controlled_terms":["Cardiac Arrythmias","Valve Heart Disease","Cardiac Ischemia","Corsano CardioWatch 287-2"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct06930833","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-05-01 to 2026-10-01","comparator":null,"confidence":"structured-source","population":"ALL · 70 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.514Z","intervention":["Corsano CardioWatch 287-2"],"participants":20,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Frailty score agreement between Geriatric-8 questionnaire and CardioWatch 287-2 — From start to end of first CardioWatc…","Frailty score agreement between FRAIL questionnaire and CardioWatch 287-2 — From start to end of first CardioWatch 287-…","Frailty score agreement between 6-minute walking test and CardioWatch 287-2 — From start to end of first CardioWatch 28…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35367","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}