Tokyo, Nov. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059666) titled 'Therapy evaluation of Rhythm and heart failure with Unified cardiac device Study and Tracking' on Nov. 6.

Study Type: Observational

Primary Sponsor: Institute - The univerity of Osaka

Condition: Condition - Patients receiving first-time implantation of ICD, S-ICD, CRT-P, or CRT-D, as well as those undergoing device upgrades. Includes patients awaiting heart transplantation and those after heart transplantation. If the extravascular implantable cardioverter-defibrillator (EV-ICD) becomes available, that device type will also be included. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - We will establish a large, multicenter database in the continuously evolving fields of heart failure, arrhythmias, and device therapy to keep treatment strategies updated to the state of the art. Using long-term, large-scale multicenter data, we will conduct integrated analyses of patient characteristics, pathophysiologic assessments, and outcome information to: 1.Continuously refine optimal interventional and pharmacologic therapies. 2.Examine the relationships between patient factors and clinical outcomes. 3.Explore optimization of healthcare systems and societal resources. 4.Collect clinical data to enable real-world implementation of biomedical informatics and AI technologies. Through these long-term, multifaceted investigations, our goal is to generate insights that promote earlier diagnosis and detection and ultimately improve patient outcomes. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients who received ICD/S-ICD/CRT-P/CRT-D (and, when available, EV-ICD) implantation at participating sites, including upgrades from pacemakers. Aged 18 years or older. Able to undergo regular follow-up. Key exclusion criteria - Patients with a non-cardiac condition diagnosed as having a life expectancy of <=1 year. Patients who decline to participate in the study. Any other individuals deemed unsuitable by the principal investigator or co-investigators. Target Size - 1000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 03 Month 21 Day Anticipated trial start date - 2025 Year 12 Month 08 Day Last follow-up date - 2036 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068131

Disclaimer: Curated by HT Syndication.