Completed

CAFCASThe Canadian Atrial Fibrillation Force Contact Ablation Study

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cardiovascular Diseases+3

+ Heart Diseases

+ Pathologic Processes

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2012
See protocol details

Summary

Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: March 31, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: March 31, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmias, CardiacAtrial Fibrillation

Criteria

5 inclusion criteria required to participate
At least one episode of AF must have been documented on telemetry, ambulatory monitor, or 12-lead ECG

Patients aged 18 years or greater

Patients must be able and willing to provide written informed consent to participate in the clinical study

Patients undergoing first-time pulmonary vein catheter ablation for AF

Show More Criteria

4 exclusion criteria prevent from participating
Patients who are or may potentially be pregnant

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

London Health Sciences Centre

London, CanadaOpen London Health Sciences Centre in Google Maps
CompletedOne Study Center