Atrial Fibrillation Force Contact Ablation Study

Paroxysmal Atrial Fibrillation Clinical Trial

— CAFCAS  

Official title:

The Canadian Atrial Fibrillation Force Contact Ablation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693107
• Other study ID #: Version 20120423
• Status: Completed
• Start date: September 2012
• Est. completion date: January 2015

Study information

• Verified date: September 2012
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Atrial fibrillation (AF) is the most common arrhythmia affecting over 5% of the population above the age of 65 years. The use of percutaneous catheter ablation for symptomatic management has increased over the last decade. It is well established that AF ablation is superior to anti-arrhythmic drugs for symptomatic recurrence of AF. Despite this, success rates with a single procedure for paroxysmal AF is approximately 80% with the majority of recurrence due to recovery of lesions or "gaps" found at repeat procedures.

In this study, patients with symptomatic paroxysmal atrial fibrillation (AF) will undergo ablation using a newly Health Canada approved catheter with SmartTouch technology that enables the measurement of catheter tip contact force and direction inside the heart. The purpose of Phase I of the study 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.

The secondary objective will be to assess whether lesion recovery, as assessed in redo procedures, corresponds to contact force measurements. It is hypothesized that gaps found on repeat procedures will correspond to ablation lesions associated with a lower contact force.

In Phase II, 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 SmartTouch catheter. It is hypothesized that the open use of contact force data will decrease the procedural time and number of lesions to achieve bidirectional pulmonary vein isolation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lesion Recovery	Localization of recovered gaps	up to 1 year
Secondary	Ablation Time	Total time of ablation used during procedure	participants will be followed for the duration of hospital stay, an expected average of 36 hours
Secondary	Number of ablation lesions	Total number of ablation lesions to achieve bidirectional block of all 4 pulmonary veins	participants will be followed for the duration of hospital stay, an expected average of 36 hours