Clinical trial NCT01851525: Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
Official title: Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial fibrillation
Ablation
Lead sponsor: Southlake Regional Health Centre
Sponsor class: OTHER
Collaborators: name: Applied Health Research Centre
First posted: 2013-05-10
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete\& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Direct contact force sensing (CFS) is a novel technology that may help to ensure adequate lesion delivery. CFS may also help to improve the safety profile of catheter ablation. The purpose of this study is to compare two strategies of wide antral PV isolation plus linear ablation for persistent AF:

1. guided by contact force sensing (CFS) OR
2. blinded to contact force sensing (CFS) - i.e. standard approach


Eligibility criteria: Inclusion Criteria

* Age \> 18 years.
* Patients undergoing first-time catheter ablation for AF.
* Persistent AF defined as episodes greater than 7 days duration.
* Symptomatic AF defined as patients who have been aware of their AF anytime within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
* At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 24 months of enrolment.
* Willing and able to provide informed consent.

Exclusion Criteria

* Paroxysmal AF.
* AF secondary to a reversible cause.
* Patients with contraindications to systemic anticoagulation with heparin, coumadin, or a direct thrombin inhibitor.
* Patients who have previously undergone AF ablation.
* Patients with left atrial size \>55 mm (echocardiography, parasternal long axis view).
* Patients who are or may potentially be pregnant.

Primary outcomes:
measure: Total cumulative radio frequency (RF) delivery time
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from AF or atrial arrhythmia >30 sec
timeFrame: 12 months
measure: Ability to achieve PV isolation with a single ring of lesions around each PV
timeFrame: 6 hours
measure: Ability to achieve linear ablation with complete conduction block on the first attempt
timeFrame: 6 hours
measure: Number & location of conduction gaps after initial circumferential ablation lines
timeFrame: 6 hours
measure: Number & location of conduction gaps after initial linear ablation
timeFrame: 6 hours
measure: Time required for successful PV isolation
timeFrame: 12 months
measure: Time required for successful linear ablation
timeFrame: 12 months
measure: Total fast anatomical mapping (FAM) time
timeFrame: 12 months
measure: FAM volume
timeFrame: 12 months
measure: Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis
timeFrame: 90 days
measure: Incidence of repeat ablation procedures
timeFrame: 12 months
measure: Incidence of conduction gaps around pulmonary veins
timeFrame: 12 months
measure: Freedom from atrial arrhythmia > 30 sec
timeFrame: 12 months
measure: Freedom from atrial arrhythmia > 30 sec after one or two procedures
timeFrame: 12 months
measure: Reduction in atrial arrhythmia burden by >90%
timeFrame: 12 months
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Vancouver Island Cardiac Arrhythmia Clinic
state: British Columbia
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec City
country: Canada
facility: Laval University Cardiac and Pulmonary Institute
state: Quebec
Study officials:
affiliation: Southlake Regional Health Centre
name: Atul Verma, MD
role: PRINCIPAL_INVESTIGATOR
References: