Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter

Study Overview
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Brief Summary
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The purpose of this study is a feasibility study for the Rhythmia Medical Mapping System and Mapping Catheter on patients undergoing catheter ablation procedures for the treatment of cardiac tachyarrhythmias.

Official Title
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Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter

Conditions
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Cardiac Arrhythmias

Intervention / Treatment
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* Device: Rhythmia Mapping System and the Rhythmia Mapping Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient understands the implications of participating in the study and provides informed consent Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone Patients referred for a catheter ablation procedure to treat an atrial or ventricular arrhythmia Patient can be heparinized during the procedure Exclusion Criteria: Patients requiring an emergency ablation procedure Patients hemodynamically unstable Patients with NYHA Class III or IV heart failure Women who are pregnant or lactating Patients having cardiac surgery within the past two months Patients with Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes Patients with intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction Patients with acute myocardial infarction within 3 months Patients awaiting cardiac transplantation Patients enrolled in any other clinical study Patients with an age <18 or >75 years Patients with stable/unstable angina or ongoing myocardial ischemia Patients with congenital heart disease (not including atrial septal defect (ASD) or patent foramen ovale (PFO) without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure Patients with pulmonary hypertension (mean or systolic pulmonary artery (PA) pressure > 50mm Hg on Doppler echo) Patients with a left atrial diameter > 55 mm Patients with any arrhythmia currently being treated where the arrhythmia or the management may interfere with this study Patients with active infection or sepsis Patients with untreatable allergy to contrast media Patients with a history of blood clotting (bleeding or thrombotic) abnormalities Patients with any known sensitivities to heparin or warfarin Patients with severe chronic obstructive pulmonary disease (COPD) (identified by a forced expiratory volume [FEV1] <1) Patients with severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rhythmia Mapping System & Catheter<br>This is a single arm diagnostic feasibility study with the Rhythmia Mapping System and the Rhythmia Mapping Catheter | Device: Rhythmia Mapping System and the Rhythmia Mapping Catheter<br>* Patients will undergo a diagnostic assessment with the Rhythmia Mapping System and the Rhythmia Mapping Catheter as part of the Electrophysiology Ablation Procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major device related adverse cardiac and cerebrovascular events |  | 30 days | 
| Device Performance |  | 1 day- Procedure |