Hybrid epicardial and endocardial sinus node–sparing ablation therapy for inappropriate sinus tachycardia: Rationale and design of the multicenter HEAL-IST IDE trial
Why the study?
Medical therapy is ineffective for up to 30% of inappropriate sinus tachycardia patients, while catheter ablation carries high recurrence and complication rates, prompting evaluation of a novel hybrid sinus node-sparing approach.
Does hybrid epicardial and endocardial sinus node-sparing ablation improve freedom from inappropriate sinus tachycardia in patients with symptomatic, drug-refractory or drug-intolerant IST?
Population
Up to 142 subjects with symptomatic, drug-refractory or drug-intolerant inappropriate sinus tachycardia
Comparison
Hybrid epicardial and endocardial sinus node-sparing ablation procedure
Design
Prospective, multicenter, pivotal, single-arm trial with a Bayesian adaptive design
Follow-up
12 months
Authors
Discussion
Loading...
Member takes
Implication
The HEAL-IST trial is designed to evaluate the safety and effectiveness of a novel hybrid sinus node-sparing ablation approach for patients with symptomatic, drug-refractory inappropriate sinus tachycardia.
Structured PICO
Does hybrid epicardial and endocardial sinus node-sparing ablation improve freedom from inappropriate sinus tachycardia in patients with symptomatic, drug-refractory or drug-intolerant IST?
P
Population
Up to 142 subjects with symptomatic, drug-refractory or drug-intolerant inappropriate sinus tachycardia (IST)
I
Intervention
Hybrid epicardial and endocardial sinus node-sparing ablation procedure
O
Outcome
Primary safety through 30 days post-procedure and primary effectiveness (freedom from IST at 12 months, defined as mean heart rate ≤90 beats/min or ≥15% reduction in mean heart rate compared with baseline without new/higher dosage of previously failed medications)composite
The HEAL-IST trial is designed to evaluate the safety and effectiveness of a novel hybrid sinus node-sparing ablation approach for patients with symptomatic, drug-refractory inappropriate sinus tachycardia.
Cite This Study
Asmundis et al. (2023) studied this question.