Cardiac Arrhythmias
Conditions
Brief summary
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.
Interventions
DEVICERhythmia Mapping System and the Rhythmia Mapping Catheter
Patients will undergo a diagnostic assessment with the Rhythmia Mapping System and the Rhythmia Mapping Catheter as part of the Electrophysiology Ablation Procedure.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient understands the implications of participating in the study and provides informed consent 2. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone 3. Patients referred for a catheter ablation procedure to treat an atrial or ventricular arrhythmia 4. Patient can be heparinized during the procedure
Exclusion criteria
1. Patients requiring an emergency ablation procedure 2. Patients hemodynamically unstable 3. Patients with NYHA Class III or IV heart failure 4. Women who are pregnant or lactating 5. Patients having cardiac surgery within the past two months 6. Patients with Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes 7. Patients with intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction 8. Patients with acute myocardial infarction within 3 months 9. Patients awaiting cardiac transplantation 10. Patients enrolled in any other clinical study 11. Patients with an age \<18 or \>75 years 12. Patients with stable/unstable angina or ongoing myocardial ischemia 13. 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 14. Patients with pulmonary hypertension (mean or systolic pulmonary artery (PA) pressure \> 50mm Hg on Doppler echo) 15. Patients with a left atrial diameter \> 55 mm 16. Patients with any arrhythmia currently being treated where the arrhythmia or the management may interfere with this study 17. Patients with active infection or sepsis 18. Patients with untreatable allergy to contrast media 19. Patients with a history of blood clotting (bleeding or thrombotic) abnormalities 20. Patients with any known sensitivities to heparin or warfarin 21. Patients with severe chronic obstructive pulmonary disease (COPD) (identified by a forced expiratory volume \[FEV1\] \<1) 22. 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major device related adverse cardiac and cerebrovascular events | 30 days |
| Device Performance | 1 day- Procedure |
Countries
Canada
Outcome results
None listed