Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059339) titled 'Feasibility and Efficacy of Intra-procedural Direct Current Cardioversion During Structural Heart Interventions in Patients With Atrial Fibrillation: A Prospective Study' on Oct. 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - St. Marianna University School of Medicine
Condition:
Condition - Atrial fibrillation, aortic stenosis, mitral regurgitation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the feasibility and efficacy of intra-procedural direct current cardioversion for atrial fibrillation during transcatheter aortic valve implantation or mitral transcatheter edge-to-edge repair
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Direct current cardioversion
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients with atrial fibrillation deemed suitable for TAVI or M-TEER by a local heart team and undergoing the procedure under general anesthesia
Key exclusion criteria - Patients who have paroxysmal atrial fibrillation and present with sinus rhythm during the procedure
Patients who undergo TAVI or M-TEER under local anesthesia
Patients with intracardiac thrombus
Patients who are ineligible for direct current cardioversion for any reason
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 06 Day
Date of IRB - 2025 Year 10 Month 06 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2030 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067871
Disclaimer: Curated by HT Syndication.
