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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmias
• Intervention / Treatment: Device: Rhythmia Mapping System and the Rhythmia Mapping Catheter

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Rhythmia Mapping System & Catheter; 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; Patients will undergo a diagnostic assessment with the Rhythmia Mapping System and the Rhythmia Mapping Catheter as part of the Electrophysiology Ablation Procedure.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 13, 2012
• First Submitted That Met QC Criteria: July 13, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: TP000-147