NCT06188351

Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture

A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Three Dimensional Navigation Intracardiac Guidance Kit for Atrial Septal Puncture

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and efficacy of a three-dimensional navigation intracardiac guidance kit to perform atrial septal puncture in patients requiring catheter ablation, which will be compared with procedures using traditional kit for atrial septal puncture.

Detailed description

Atrial septal puncture has become a key technique in cardiac interventional procedures. Traditional septal punctures are routinely perfomed under two-dimensioanl guidance, whic are likely to be not acurate sometimes. This study is aimed to study the safety and efficacy of a novel designed three-dimensional navigation Intracardiac guidance kit for atrial septal puncture in patients with atrial fibrillation requiring catheter ablation and to explore the possibility of transseptal without fluoroscopy using the three-dimensional positioning intracardiac guidance.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Three-Dimensional Navigation Atrial Septal Puncture	Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit
DEVICE	Conventional Atrial Septal Puncture	Atrial septal puncture will be performed using traditioanl two-dimensional atrial septal puncture kit using traditional method.

Timeline

• Start date: 2023-04-24
• Primary completion: 2024-06-01
• Completion: 2024-09-01
• First posted: 2024-01-03
• Last updated: 2024-01-03

Locations

1 site across 1 country: China