Clinical Trial

HEAL-IST IDE Trial

Active, Not Recruiting
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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.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2022-03-04; most recent amendment 2026-02-26.
Status change: Recruiting → Active, Not Recruiting 2026-02-18
Status change: Enrolling by Invitation → Recruiting 2023-05-02
Status change: Not Yet Recruiting → Enrolling by Invitation 2022-06-15
Trial Details
NCT Number NCT05280093
Lead Sponsor AtriCure, Inc.
Conditions Inappropriate Sinus Tachycardia
Enrollment 142 participants
Start Date 2022-05-31
Primary Completion 2027-02 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-02