NCT05375110

NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)

A Prospective, Multi-center and Objective Performance Criteria Study to Evaluate the Effectiveness and Safety of NoYA™ Radiofrequency Interatrial Shunt System for the Treatment of Chronic Heart Failure With Elevated Left Atrial Pressure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hangzhou NOYA MedTech Co. Ltm. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Multiple Center, and Objective Performance Criteria Study to Evaluate the NoYA™ Radiofrequency Interatrial Shunt System manufactured by NoYA Medtech (Hangzhou) Co., Ltd. for the Treatment of Chronic Heart Failure with Elevated Left Atrial Pressure.

Detailed description

This is a prospective, multi-center and objective performance criteria study to evaluate the effectiveness and safety of the NoYA™ Radiofrequency Interatrial Shunt System for the treatment of chronic heart failure with elevated left atrial pressure. Patients with chronic heart failure with elevated left atrial pressure who meet study eligibility criteria will be enrolled and undergo radiofrequency ablation of the interatrial procedure with NoYA™ Radiofrequency Interatrial Shunt System (Noya Medtech) after signing the informed consent. The follow-up will be conducted at discharge, 1 month, 3 months, 6 months, and 12 months after the operation.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	NoYA™ Radiofrequency Interatrial Shunt System	NoYA™ Radiofrequency Interatrial Shunt System include Adjustable Interatrial Shunt System and Radiofrequency Ablation Generator.

Timeline

• Start date: 2021-03-10
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2022-05-16
• Last updated: 2022-05-16

Locations

31 sites across 1 country: China