NCT04770142

First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation

The Study for Evaluation of Safety and Efficacy of Transcatheter RF Ablation System (TIRA Catheter) to Treat Hypertrophic Obstructive Cardiomyopathy : Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Tau-MEDICAL Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.

Detailed description

The objective of this multi-center, open label, single arm, investigator initiated exploratory pilot study is to evaluation of safety and efficacy of transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices), in treating hypertrophic obstructive cardiomyopathy(HOCM).

Conditions

• Hypertrophic Obstructive Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	TIRA catheter	treat hypertrophic obstructive cardiomyopathy

Timeline

• Start date: 2021-04-21
• Primary completion: 2024-07-02
• Completion: 2025-04-08
• First posted: 2021-02-25
• Last updated: 2025-04-16

Locations

9 sites across 1 country: South Korea