Pre close versus post close using suture-mediated closure system for catheter ablation

UMIN ID: UMIN000049174

Registered date:01/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: tachycardia
• Date of first enrollment: 2022/10/05
• Target sample size: 280
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Pre close
Post close

Outcome(s)

• Primary Outcome: The primary efficacy endpoint was rebleeding rate requiring recompression during immobilization, bedrest and after ambulation. The primary safety endpoint is the incidence of major complications related to venous access site closure at 90days.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclusion criteria included vascular surgery or catheter ablation within the last three months, active systemic or cutaneous infection or inflammation in the vicinity of the groin, any preexisting immunodeficiency disorder, long term use of high dose systemic steroids, history of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events, platelet count over 100,000 cells per mm, or severe comorbidities with life expectancy 12 months in the opinion of the site investigator. After providing informed consent, patients underwent the appropriate ablation procedure

Related Information

• Primary Sponsor: Toyama Prefectural Central Hospital
• Source(s) of Monetary Support: Toyama Prefectural Central Hospital