Atrial Fibrillation Force Contact Ablation Study

NCT01693107 | Completed

• 1 other identifier: Version 20120423
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be divided into two phases. The purpose of the Phase I registry is to assess the current force being used for ablation of symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the operators being blinded to the contact force data. In Phase II of the study, operators will have open use of the force contact data. Phase I and II data will be compared in order to assess the efficiency of using the THERMOCOOL® SMARTTOUCH™ catheter.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Atrial Fibrillation; Catheter Ablation; Electrophysiology; Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (1)

• Procedural Time

  Length of time between first ablation and last ablation

  participants will be followed for the duration of hospital stay, an expected average of 36 hours

Secondary Outcomes (3)

• Lesion Recovery

  up to 1 year

• Ablation Time

  participants will be followed for the duration of hospital stay, an expected average of 36 hours

• Number of ablation lesions

  participants will be followed for the duration of hospital stay, an expected average of 36 hours

Study Arms (1)

Operator Blinded to Contact Force

Physicians performing the ablation will be blinded to the contact force data

Eligibility Criteria

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

Study Population

Patients with symptomatic paroxysmal atrial fibrillation who have failed antiarrhythmic medications and scheduled for a pulmonary vein isolation procedure.

You may qualify if:

• Patients aged 18 years or greater.
• Patients undergoing first-time pulmonary vein catheter ablation for AF.
• Patients with paroxysmal AF. Paroxysmal AF will be defined as symptomatic episodes of AF lasting less than 7 days or treated with cardioversion(s) within 48 hours of onset.
• At least one episode of AF must have been documented on telemetry, ambulatory monitor, or 12-lead ECG.
• Patients must be able and willing to provide written informed consent to participate in the clinical study.

You may not qualify if:

• Patients with a history of any previous ablation for atrial fibrillation.
• Patients with a previous atriotomy scar, ie. Mitral or tricuspid valve replacement or repair, ASD surgery, cardiac transplant.
• Patients with an intracardiac thrombus
• Patients who are or may potentially be pregnant.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Leong-Sit, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2015
• Last Updated: March 31, 2020

Record last verified: 2012-09

Locations

CA (1)