Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05280093

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inappropriate Sinus Tachycardia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussels, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years and ≤ 75 years at time of enrollment consent
  • Subject has a diagnosis of IST
  • Documentation of refractoriness (intolerance or failure) of a drug (e.g., rate control drugs such as beta-blockers/calcium channel blockers, ivabradine), and/or AADs
  • Subject is willing and able to provide written informed consent

Exclusion criteria

  • Subjects on whom cardiac surgery or single lung ventilation cannot be performed
  • Subjects with indication for or existing ICDs/Pacemakers
  • Presence of channelopathies
  • Previous cardio-thoracic surgery
  • Left Ventricular Ejection Fraction (LVEF) < 50%
  • Body Mass Index (BMI) ≥ 35
  • Presence of supraventricular or ventricular tachycardia
  • Presence of Postural Orthostatic Sinus Tachycardia (POTS)
  • Presence of congenital heart disease
  • History suggestive of secondary cause of tachycardia such as pheochromocytoma, anemia, thyrotoxicosis, chronic fever of unknown origin, COPD, long-term bronchodilators use, severe asthma or carcinoid syndrome
  • Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders
  • Life expectancy < 24 months
  • Pregnant or planning to become pregnant during trial
  • Subjects with substance abuse
  • Subjects with previous weight loss surgery
  • Subject is unwilling and/or unable to return for scheduled follow-up visits
  • Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a trial that may interfere with trial results
  • Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and;
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

Treatment and study plan

AtriCure ISOLATOR Synergy Surgical Ablation System

Device

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

Primary outcomes

  1. Primary Effectiveness Endpoint

    Time frame: 12-months Post Procedure

    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.

  2. Primary Safety Endpoint

    Time frame: 30-days Post Procedure

    Incidence of device or procedure-related major adverse events (MAEs) for subjects undergoing the hybrid sinus node sparing ablation procedure from the index procedure through 30-days post procedure

Secondary outcomes

  1. 6-Minute Walk Test

    Time frame: 24-months Post Procedure

    Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure

  2. Borg dyspnea score

    Time frame: 24-months Post Procedure

    Change in Borg dyspnea severity of breathlessness and fatigue score from baseline compared to 6-, 12- and 24-months post-procedure. Borg dyspnea score will be assessed at each of the 6-MWT.

  3. Self-Rating Anxiety Scale

    Time frame: 24-months Post Procedure

    Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS)

  4. IST symptom reduction

    Time frame: 24-months Post Procedure

    IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure

  5. QoL - SF-12

    Time frame: 24-months Post Procedure

    Change in QoL based on a Short Form Survey (SF-12) domain and component scores at baseline compared to 6-, 12- and 24-months post-procedure

  6. Mean heart rate

    Time frame: 24-months Post Procedure

    Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring

  7. Reduction in mean heart rate in the absence of rate control drugs

    Time frame: 24-months Post Procedure

    Freedom from IST or at least 15% reduction in mean heart rate at 12- and 24-months compared to baseline, in the absence of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs

  8. Reduction in mean heart rate regardless of rate control drugs

    Time frame: 24-months Post Procedure

    Freedom from IST or at least a 15% reduction in mean heart rate at 12- and 24-months compared to baseline, regardless of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs

  9. Device or procedure related Serious Adverse Events

    Time frame: 12-months Post Procedure

    Device or procedure related Serious Adverse Events (SAEs) through 12-months

  10. Improved heart rate variability - 7-day monitor

    Time frame: 12-months Post Procedure

    Improved heart rate variability for subjects using 7-day continuous monitoring

  11. Improved heart rate variability - Implantable loop recorder

    Time frame: 12-months Post Procedure

    Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)

  12. Health Economics

    Time frame: 24-months Post Procedure

    Health Economics: ER visits and readmissions

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Mar 15, 2022
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.