Status:
UNKNOWN
Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
Lead Sponsor:
NeuTrace, Inc.
Conditions:
Arrhythmias, Cardiac
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The trial is a prospective, non-randomized, single-arm feasibility trial to evaluate physician acceptance of the NeuTrace System v1.0 for cardiac electroanatomic mapping.
Detailed Description
Arrhythmias, or abnormal heart rhythms, are a major cause of morbidity and mortality worldwide. In patients with arrhythmias, electrophysiology (EP) studies are often performed to assess the electrica...
Eligibility Criteria
Inclusion
- Patient with standard indications for an electrophysiology study and/or catheter ablation per European Heart Rhythm Association/Heart Rhythm Society) guidelines and/or judgement of the investigator
- Age 18 to 80
- Signed Informed Consent Form
Exclusion
- Any cardiac surgery, myocardial infarction, percutaneous coronary intervention/percutaneous transluminal coronary angioplasty, or coronary artery stenting which occurred during the 90-day interval preceding the date that participant signed the Informed Consent Form
- Unstable angina
- NHYA class III or IV congestive heart failure and/or known left ventricular ejection fraction less than 45%
- Thrombocytosis, thrombocytopenia
- Contraindication to anticoagulation therapy
- Active systemic infection
- Cryoglobulinemia
- Known reversible causes of arrhythmia
- Any cerebral ischemic event (stroke or transient ischemic attacks) which occurred during the 180-day interval preceding the date the participant signed the Informed Consent Form, or any known unresolved complications from the previous stroke/transient ischemic attack
- Pregnancy
- Unwilling or unable to comply fully with study procedures
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 7 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05214170
Start Date
June 7 2021
End Date
June 7 2024
Last Update
April 7 2023
Active Locations (1)
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1
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania, 08661