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

Cardiac Arrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642537
• Other study ID #: TP000-147
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major device related adverse cardiac and cerebrovascular events		30 days
Primary	Device Performance		1 day- Procedure