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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01642537
First received: July 13, 2012
Last updated: July 24, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Cardiac Arrhythmias
Device: Rhythmia Mapping System and the Rhythmia Mapping Catheter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Major device related adverse cardiac and cerebrovascular events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Device Performance [ Time Frame: Acute ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: November 2012
Study Completion Date: January 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642537

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01642537     History of Changes
Other Study ID Numbers: TP000-147
Study First Received: July 13, 2012
Last Updated: July 24, 2015
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 02, 2015