HEAL-IST IDE Trial

Not Applicable

Recruiting

• Conditions: Inappropriate Sinus Tachycardia

• Registration Number: NCT05280093
• Lead Sponsor: AtriCure, Inc.

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

Not available

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-15
• Study Start: 2022-05-31
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Age ≥ 18 years and ≤ 75 years at time of enrollment consent
2. Subject has a diagnosis of IST
3. 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
4. Subject is willing and able to provide written informed consent

Exclusion Criteria

1. Subjects on whom cardiac surgery or single lung ventilation cannot be performed
2. Subjects with indication for or existing ICDs/Pacemakers
3. Presence of channelopathies
4. Previous cardio-thoracic surgery
5. Left Ventricular Ejection Fraction (LVEF) < 50%
6. Body Mass Index (BMI) ≥ 35
7. Presence of supraventricular or ventricular tachycardia
8. Presence of Postural Orthostatic Sinus Tachycardia (POTS)
9. Presence of congenital heart disease
10. 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
11. Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders
12. Life expectancy < 24 months
13. Pregnant or planning to become pregnant during trial
14. Subjects with substance abuse
15. Subjects with previous weight loss surgery
16. Subject is unwilling and/or unable to return for scheduled follow-up visits
17. 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
18. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and;
19. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	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.
Primary Safety Endpoint	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 Outcome Measures

Name	Time	Method
Reduction in mean heart rate in the absence of rate control drugs	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
Improved heart rate variability - 7-day monitor	12-months Post Procedure	Improved heart rate variability for subjects using 7-day continuous monitoring
6-Minute Walk Test	24-months Post Procedure	Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure
Self-Rating Anxiety Scale	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)
Mean heart rate	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
Reduction in mean heart rate regardless of rate control drugs	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
Health Economics	24-months Post Procedure	Health Economics: ER visits and readmissions
QoL - SF-12	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
Device or procedure related Serious Adverse Events	12-months Post Procedure	Device or procedure related Serious Adverse Events (SAEs) through 12-months
Borg dyspnea score	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.
IST symptom reduction	24-months Post Procedure	IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure
Improved heart rate variability - Implantable loop recorder	12-months Post Procedure	Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)

Trial Locations

Locations (26)

Loma Linda University Health; 🇺🇸 Loma Linda, California, United States

Sequoia Hospital; 🇺🇸 Redwood City, California, United States

Stanford University; 🇺🇸 Redwood City, California, United States

Saint Vincent's Medical Center; 🇺🇸 Bridgeport, Connecticut, United States

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Baptist Health; 🇺🇸 Miami, Florida, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

St. Joseph's Hospital / Baycare Health System; 🇺🇸 Tampa, Florida, United States

Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States

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