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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01642537
First Posted: July 17, 2012
Last Update Posted: May 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  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: None (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 ]
  • Device Performance [ Time Frame: 1 day- Procedure ]

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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642537


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

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01642537     History of Changes
Other Study ID Numbers: TP000-147
First Submitted: July 13, 2012
First Posted: July 17, 2012
Last Update Posted: May 25, 2016
Last Verified: May 2016

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