NL-OMON56360尚未招募不适用
Hybrid Epicardial and Endocardial Sinus-Node SpAring AbLation Therapy for Inappropriate Sinus Tachycardia - HEAL-IST IDE-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years and <= 75 years at time of enrollment consent
- •2. Subject has a diagnosis of IST:
- •a. Documentation of mean heart rate > 90bpm with 7-day monitor within 90 days
- •of the Index Procedure and;
- •b. Documentation of a resting heart rate of >100bpm and;
- •c. Documentation of presence of IST for at least 6-months
- •d. Documentation of absence of other tachycardia
- •e. Documentation of absence of secondary causes such as hormonal issues or
- •systemic illness that might contribute to increased heart rate
- •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
排除标准
- •1. Subjects on whom cardiac surgery or single lung ventilation cannot be
- •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;
- •Allowed catheter ablation in the right atrium:
- •a) One previous catheter ablation > 90 days prior to the Index
- •Procedure for AVRT or CTI
- •b) One previous catheter ablation > 180 days prior to the Index
- •Procedure for AVNRT
- •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
研究者
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