Phase
Condition
Circulation Disorders
Treatment
Rhythmia Mapping System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 or above, or above legal age and willing and capable of giving informedconsent specific to national law
Scheduled for standard of care catheter-based endocardial mapping for atrial orventricular tachyarrhythmias using a commercial Rhythmia Mapping System.
Exclusion
Exclusion Criteria:
Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia
Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia,allergy, etc.)
Prosthetic or stenotic valves in the chamber where the intended mapping will occur,or in the path of the catheter access route
Active systemic infection or sepsis
Hemodynamic instability or shock at baseline precluding ablation in the assessmentof the investigator.
Presence of intracardiac thrombus, tumor, or other abnormality which precludescatheter introduction
Women who are pregnant or lactating
Cardiac surgery within the past 90 days
Acute myocardial infarction within 3 months
Stable/unstable angina or ongoing myocardial ischemia
Subjects with an active heart failure decompensation
Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
Congenital heart disease with or without corrective surgery that would complicate amapping procedure
Subjects having untreatable allergy to contrast media
Vascular pathology or tortuosity precluding standard vascular access techniques
Subjects who are currently enrolled in another investigational study or registrythat would directly interfere with the current study, except when the patient isparticipating in a mandatory governmental registry, or a purely observationalregistry with no associated treatments. Each instance should be brought to theattention of the sponsor to determine eligibility.
Study Design
Study Description
Connect with a study center
Fondazione Centro San Raffaele
Milan, MI 20132
ItalyCompleted
Centre Hospitalier Princesse Grace
Monaco, 98000
MonacoActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesCompleted
St. Lukes Idaho Cardiology Associates
Boise, Idaho 83712
United StatesCompleted
Lahey Clinic, Inc.
Burlington, Massachusetts 01805
United StatesCompleted
Catholic Medical Center
Manchester, New Hampshire 03102
United StatesActive - Recruiting
Valley Hospital
Ridgewood, New Jersey 07450-2736
United StatesCompleted
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