Tokyo, Feb. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060737) titled 'A Multicenter Observational Study of Pacemaker Implantation in Patients With Advanced Atrioventricular Block and Preserved or Moderately Reduced Left Ventricular Ejection Fraction (>35%)' on Feb. 24.
Study Type:
Observational
Primary Sponsor:
Institute - Nihon University
Condition:
Condition - Advanced atrioventricular block (including complete atrioventricular block)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to investigate the real-world implantation rates of various cardiac pacing devices in patients with advanced atrioventricular block and left ventricular ejection fraction greater than 35% who are expected to require ventricular pacing, to evaluate the reasons for device selection and differences in clinical outcomes, and to assess the impact of pacing site and pacing mode on cardiac function and infection risk.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
20%), left ventricular ejection fraction greater than 35%, and first implantation of a cardiac implantable device
Key exclusion criteria - (1) Patients who are not expected to survive for at least 12 months
(2) Patients with drug-refractory severe congestive heart failure classified as NYHA functional class IV who are not candidates for heart transplantation, CRT, or LVAD
(3) Patients who expressed refusal to participate in this study
(4) Patients deemed inappropriate as study subjects by the principal investigator
Target Size - 400
Recruitment Status:
Recruitment status - Suspended
Date of protocol fixation - 2025 Year 11 Month 04 Day
Date of IRB - 2025 Year 12 Month 10 Day
Anticipated trial start date - 2026 Year 03 Month 02 Day
Last follow-up date - 2027 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069486
Disclaimer: Curated by HT Syndication.
