Tokyo, June 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061421) titled 'Clinical Outcomes of Left Bundle Branch Area and BachmaNn BunDle Pacing: Multicenter ReAl-World Registry in Kanagawa (LANDMARK study)' on June 2.
Study Type:
Observational
Primary Sponsor:
Institute - LANDMARK study investigators
Condition:
Condition - All patients undergoing pacemaker-related procedures at participating institutions will be included. Pacemaker therapy is defined as transvenous implantation of a conventional pacemaker, an implantable cardiac defibrillator (ICD), or cardiac resynchronization therapy (CRT) device; leadless pacemakers are excluded.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This multicenter study aims to evaluate the clinical outcomes of left bundle branch area pacing LBBAP and bundle branch pacing BBP in Japan among patients with symptomatic bradycardia and those with heart failure requiring pacing To better reflect real world clinical practice non conduction system pacing non CSP cases including right ventricular septal pacing RVSP as well as atrial pacing sites will also be registered
Accordingly this design will enable
1 assessment of the safety and efficacy of LBBAP through comparison with the non CSP group
2 evaluation of the effectiveness of LBBAP in patients undergoing cardiac resynchronization therapy CRT and
3 analysis of the impact of atrial pacing site on clinical outcomes
Furthermore by conducting a five year follow up after completion of patient enrollment this study is expected to clarify the long term effects of physiological pacing on the preservation of cardiac function and its contribution to clinical outcomes
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 12
years-old
Gender - Male and Female
Key inclusion criteria - All patients undergoing pacemaker-related procedures will be included. Pacemaker therapy is defined as transvenous implantation of a conventional pacemaker, an implantable cardiac defibrillator ICD, or cardiac resynchronization therapy CRT device.
Key exclusion criteria - Patients who underwent leadless pacemaker
Target Size - 2000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 01 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2033 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070262
Disclaimer: Curated by HT Syndication.
