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

Primary Purpose

Cardiac Arrhythmias

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rhythmia Mapping System and the Rhythmia Mapping Catheter
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Arrhythmias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Rhythmia Mapping System & Catheter

Arm Description

This is a single arm diagnostic feasibility study with the Rhythmia Mapping System and the Rhythmia Mapping Catheter

Outcomes

Primary Outcome Measures

Major device related adverse cardiac and cerebrovascular events
Device Performance

Secondary Outcome Measures

Full Information

First Posted
July 13, 2012
Last Updated
June 3, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01642537
Brief Title
Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter
Official Title
Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmias

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhythmia Mapping System & Catheter
Arm Type
Other
Arm Description
This is a single arm diagnostic feasibility study with the Rhythmia Mapping System and the Rhythmia Mapping Catheter
Intervention Type
Device
Intervention Name(s)
Rhythmia Mapping System and the Rhythmia Mapping Catheter
Intervention Description
Patients will undergo a diagnostic assessment with the Rhythmia Mapping System and the Rhythmia Mapping Catheter as part of the Electrophysiology Ablation Procedure.
Primary Outcome Measure Information:
Title
Major device related adverse cardiac and cerebrovascular events
Time Frame
30 days
Title
Device Performance
Time Frame
1 day- Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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