Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-01 @ 12:18 AM
Study NCT ID:
NCT05280093
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HEAL-IST IDE Trial
Sponsor:
AtriCure, Inc.
Organization:
Study Overview
Official Title:
Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: