Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter
NCT ID: NCT01642537
Last Updated: 2021-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2012-11-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Rhythmia Mapping System & Catheter
This is a single arm diagnostic feasibility study with the Rhythmia Mapping System and the Rhythmia Mapping Catheter
Rhythmia 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.
Interventions
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Rhythmia 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.
Eligibility Criteria
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Inclusion Criteria
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
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.)
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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London Health Sciences Centre
London, Ontario, Canada
Countries
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Other Identifiers
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TP000-147
Identifier Type: -
Identifier Source: org_study_id
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