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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Rhythmia Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Rhythmia Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01642537
First received: July 13, 2012
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate the safety and performance of 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
Device: Rhythmia Mapping Catheter
Procedure: Electrophysiology

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Rhythmia Medical, Inc.:

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

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
This is a single arm study
Device: Rhythmia Mapping System Device: Rhythmia Mapping Catheter Procedure: Electrophysiology

  Eligibility

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

Inclusion Criteria:

  • Patients referred for a catheter ablation procedure to treat an atrial or ventricular arrhythmia

Exclusion Criteria:

  • Women who are pregnant
  • Patients with an age <18 or >75 years
  • Patients with intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction
  • Patients enrolled in any other clinical study
  • Patients with any known sensitivities to heparin or warfarin
  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

Contacts
Contact: Allan Skanes, MD FRCPC +1- 519- 685-8300 askanes@uwo.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Allan Skanes, MD FRCPC         
Sponsors and Collaborators
Rhythmia Medical, Inc.
  More Information

No publications provided

Responsible Party: Rhythmia Medical, Inc.
ClinicalTrials.gov Identifier: NCT01642537     History of Changes
Other Study ID Numbers: TP000-147
Study First Received: July 13, 2012
Last Updated: March 13, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 19, 2014