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

NCT01642537 | Completed

• 1 other identifier: TP000-147
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (2)

• Major device related adverse cardiac and cerebrovascular events

  30 days

• Device Performance

  1 day- Procedure

Study Arms (1)

Rhythmia Mapping System & Catheter

OTHER

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

Interventions

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.

Rhythmia Mapping System & Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2015
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

CA (1)