Hybrid Epicardial and Endocardial Sinus-Node SpAring AbLation Therapy for Inappropriate Sinus Tachycardia

• Conditions: Inappropriate Sinus Tachycardia (IST); 10007521

• Registration Number: NL-OMON56360
• Lead Sponsor: AtriCure, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

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

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;
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
results

Study & Design

• Study Type: Interventional
• Study Design: Not specified