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NCT05280093 · ClinicalTrials.gov registry record · NA
HEAL-IST IDE Trial
A NA study of Inappropriate Sinus Tachycardia, sponsored by AtriCure.
- Active
- Registry status
- NA
- Development phase
- 142
- Enrollment target
- 20
- Study locations
NCT05280093: Active NA study of Inappropriate Sinus Tachycardia, sponsored by AtriCure.
NCT05280093 is a NA study of Inappropriate Sinus Tachycardia that is active but no longer recruiting, run by AtriCure. The registered enrollment target is 142 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05280093, a NA study of Inappropriate Sinus Tachycardia, is active but no longer recruiting, sponsored by AtriCure.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 142 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Freedom from IST at 12-months. Freedom from IST is defined as mean heart rate of ≤ 90bpm or at least a 15% reduction in mean heart rate as compared to baseline, in the absence of new or higher dosage of previously failed medications.
Conditions Studied
Interventions
- DEVICE AtriCure ISOLATOR Synergy Surgical Ablation System
Study Locations (20)
Florida
- University of Florida - Gainesville
- Baptist Health - Miami
- Sarasota Memorial Hospital - Sarasota
- St. Joseph's Hospital / Baycare Health System - Tampa
California
- Loma Linda University Health - Loma Linda
- Sequoia Hospital - Redwood City
- Stanford University - Redwood City
Ohio
- TriHealth, Inc. - Cincinnati
- The Christ Hospital - Cincinnati
Arkansas
- St. Bernard - Jonesboro
Connecticut
- Saint Vincent's Medical Center - Bridgeport
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Georgia
- Memorial Health University Medical Center - Savannah
Idaho
- Saint Alphonsus Regional Medical Center - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2022-05-31 |
| Est. Completion | 2028-02 |
| Phase | NA |
What the registry record for NCT05280093 still lists
NCT05280093 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Inappropriate Sinus Tachycardia appearing as the primary indexed condition, and to 1 intervention - of which AtriCure ISOLATOR Synergy Surgical Ablation System is the first listed.
NCT05280093 names 20 study sites across 14 states, led by Florida, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05280093 about?
NCT05280093 is a clinical study titled "HEAL-IST IDE Trial". 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 tr...
What is the current status of trial NCT05280093?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 142 participants. The study started on 2022-05-31. Estimated completion is 2028-02.
What conditions does trial NCT05280093 study?
This clinical trial studies the following conditions: Inappropriate Sinus Tachycardia.
What interventions are being tested in trial NCT05280093?
The interventions under investigation include: AtriCure ISOLATOR Synergy Surgical Ablation System (DEVICE).
Who is sponsoring clinical trial NCT05280093?
This trial is sponsored by AtriCure, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05280093 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05280093's enrollment target sits among peer trials
142 711th of 2000 higher than 1,289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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