Hybrid epicardial and endocardial sinus node-sparing ablation therapy for inappropriate sinus tachycardia: Rationale and design of the multicenter HEAL-IST IDE trial

Carlo de Asmundis; Luigi Pannone; Dhanunjaya Lakkireddy; Thomas M Beaver; Chad R Brodt; Randall J Lee; Kenneth Frazier; Gian-Battista Chierchia; Mark La Meir

doi:10.1016/j.hroo.2023.01.005

Hybrid epicardial and endocardial sinus node-sparing ablation therapy for inappropriate sinus tachycardia: Rationale and design of the multicenter HEAL-IST IDE trial

Heart Rhythm O2. 2023 Jan 31;4(4):275-282. doi: 10.1016/j.hroo.2023.01.005. eCollection 2023 Apr.

Authors

Carlo de Asmundis¹, Luigi Pannone¹, Dhanunjaya Lakkireddy², Thomas M Beaver³, Chad R Brodt⁴, Randall J Lee⁵, Kenneth Frazier⁶, Gian-Battista Chierchia¹, Mark La Meir⁷

Affiliations

¹ Heart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel, European Reference Networks Guard-Heart, Brussels, Belgium.
² Kansas City Heart Rhythm Institute, Overland Park, Kansas.
³ Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, Florida.
⁴ Sequoia Hospital, Palo Alto, California.
⁵ Section of Cardiology, University of California, San Francisco, San Francisco, California.
⁶ AtriCure, Inc, Mason, Ohio.
⁷ Cardiac Surgery Department, Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel, Brussels, Belgium.

Abstract

Background: Inappropriate sinus tachycardia (IST) is defined as resting heart rate >100 beats/min and average 24-hour heart rate >90 beats/min. It is associated with distressing symptoms and significant loss of quality of life. Drugs are not effective in symptom control of IST in up to 30% of patients. Catheter ablation of the sinus node has a high recurrence rate, and the complications are significant. Recently, a novel hybrid sinus node-sparing ablation approach for IST was described.

Objective: The objective of the Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (HEAL-IST) investigational device exemption trial (NCT05280093) is to evaluate safety and effectiveness of the hybrid sinus node-sparing ablation procedure for the treatment of symptomatic, drug-refractory or drug-intolerant IST.

Methods: The HEAL-IST trial is a prospective, multicenter, pivotal, single-arm trial. Up to 142 subjects in up to 40 centers will be treated in the trial with a Bayesian adaptive design.

Results: Subjects will be assessed for primary safety through 30 days post-hybrid ablation procedure. The primary effectiveness endpoint will be freedom from IST at 12 months. Freedom from IST will be defined as mean heart rate of ≤90 beats/min or at least a 15% reduction in mean heart rate as compared with baseline, in the absence of new or higher dosage of previously failed medications at a 24-month follow-up assessment.

Conclusion: The HEAL-IST trial is the first multicenter trial evaluating hybrid IST ablation in patients with symptomatic IST and refractory or intolerant to drugs. The results of this study will help guide decision making regarding the best management in this population.

Keywords: Catheter ablation; Electrophysiological mechanism; Hybrid sinoatrial node sparing ablation; Inappropriate sinus node tachycardia; Sinoatrial node.