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OpenTrials
Completed

NCT Number: NCT01642537

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Rhythmia Mapping System and the Rhythmia Mapping Catheter

Device

Patients will undergo a diagnostic assessment with the Rhythmia Mapping System and the Rhythmia Mapping Catheter as part of the Electrophysiology Ablation Procedure.

Primary outcomes

  1. Major device related adverse cardiac and cerebrovascular events

    Time frame: 30 days

  2. Device Performance

    Time frame: 1 day- Procedure

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Jul 17, 2012
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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