Tokyo, Oct. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059261) titled 'Histological Evaluation of Atrial Fibrillation Substrate Based on Atrial Septum Biopsy 3' on Oct. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Saga University
Condition:
Condition - atrial fibrillation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To assess temporal changes in atrial histology through a second atrial biopsy and to elucidate their association with post-ablation recurrence.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Eligible patients are those who meet all of the following criteria:
1. Patients undergoing radiofrequency catheter ablation for recurrent atrial fibrillation or macroreentrant atrial tachycardia during the period from the date of issuance of the administrative approval notice until December 31, 2025.
2. Patients who previously participated in the HEAL-AF study, HEAL-AF2 study, or FUTURE-AF-S study, and who underwent atrial biopsy at the time of the prior ablation.
3. Age 20 years or older.
Key exclusion criteria - Exclusion Criteria
1. Pregnant patients or those with the possibility of pregnancy.
2. Patients with evidence of left atrial thrombus.
3. Patients deemed unsuitable for study participation by the attending physician.
Target Size - 60
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2022 Year 10 Month 03 Day
Date of IRB - 2022 Year 10 Month 03 Day
Anticipated trial start date - 2023 Year 11 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067732
Disclaimer: Curated by HT Syndication.
