NCT05280093

HEAL-IST IDE Trial

Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: AtriCure, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Inappropriate Sinus Tachycardia (IST) is a prevalent and debilitating condition in otherwise healthy younger patients, resulting in significant loss of quality of life, lacking effective treatment options or systematic clinical evidence to support a therapy. The primary objective of this clinical trial is to evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure for the treatment of symptomatic drug refractory or drug intolerant IST.

Conditions

• Inappropriate Sinus Tachycardia

Interventions

Type	Name	Description
DEVICE	AtriCure ISOLATOR Synergy Surgical Ablation System	Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

Timeline

• Start date: 2022-05-31
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2022-03-15
• Last updated: 2026-03-02

Locations

27 sites across 6 countries: United States, Belgium, Italy, Netherlands, Poland, United Kingdom

Regulatory

• FDA-regulated device study