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HEAL-IST IDE Trial

NCT05280093 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-03-02

No results posted yet for this 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.

Conditions

  • Inappropriate Sinus Tachycardia

Interventions

DEVICE

AtriCure ISOLATOR Synergy Surgical Ablation System

Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

Sponsors & Collaborators

  • AtriCure, Inc.

    lead INDUSTRY

Principal Investigators

  • Dhanunjaya Lakkireddy, MD · Kansas City Heart Rhythm Institute

  • Mark La Meir, MD · Universitair Ziekenhuis Brussel

  • Carlo de Asmundis, MD · Universitair Ziekenhuis Brussel

  • Thomas Beaver, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2027-02-28
Completion
2028-02-29
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Italy
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05280093 on ClinicalTrials.gov