Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059163) titled 'Effect of Atrioventricular Synchronous Pacing with Atrial Mechanical Sensing of Micra AV on Cardiac Output and Exercise Tolerance Micra' on Oct. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Dokkyo Medical University
Condition:
Condition - Patients with high-degree atrioventricular block or complete atrioventricular block who are candidates for leadless pacemaker implantation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate whether atrial mechanical sensing-based atrioventricular (AV) synchronous pacing using the Micra AV leadless pacemaker can improve cardiac output, hemodynamics, and exercise tolerance compared to the conventional VVI pacing mode.
Hemodynamic parameters such as cardiac output are assessed using a Swan-Ganz catheter (thermaldilution catheter) and a non-invasive cardiac output monitor. Exercise capacity is evaluated using a cardiopulmonary exercise test (CPX).
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Patients with high-degree atrioventricular block or complete atrioventricular block who are candidates for leadless pacemaker implantation.
Key exclusion criteria - Patients who are eligible for implantation of a transvenous subcutaneous implantable pacemaker
Target Size - 30
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2022 Year 08 Month 03 Day
Date of IRB - 2022 Year 08 Month 03 Day
Anticipated trial start date - 2023 Year 01 Month 01 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=R000067570
Disclaimer: Curated by HT Syndication.
