Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

Persistent Atrial Fibrillation Clinical Trial

— TOUCH AF  

Official title:

Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851525
• Other study ID #: 01
• Status: Completed
• Phase: N/A
• First received: May 5, 2013
• Last updated: April 24, 2017
• Start date: June 2013
• Est. completion date: February 15, 2017

Study information

• Verified date: April 2017
• Source: Southlake Regional Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• ThermoCoolSmartTouch ablation catheter, Biosense Webster

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Laval University Cardiac and Pulmonary Institute	Quebec City	Quebec
Canada	Vancouver Island Cardiac Arrhythmia Clinic	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Southlake Regional Health Centre	Applied Health Research Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cumulative radio frequency (RF) delivery time	Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)	12 months
Secondary	Freedom from AF or atrial arrhythmia >30 sec	Freedom from AF or atrial arrhythmia >30 sec at 12 months post-initial ablation	12 months
Secondary	Ability to achieve PV isolation with a single ring of lesions around each PV	Ability to achieve PV isolation with a single ring of lesions around each PV	6 hours
Secondary	Ability to achieve linear ablation with complete conduction block on the first attempt	Ability to achieve linear ablation with complete conduction block on the first attempt	6 hours
Secondary	Number & location of conduction gaps after initial circumferential ablation lines	Number & location of conduction gaps after initial circumferential ablation lines during first ablation procedure	6 hours
Secondary	Number & location of conduction gaps after initial linear ablation	Number & location of conduction gaps after initial linear ablation during first ablation procedure	6 hours
Secondary	Time required for successful PV isolation	Time required for successful PV isolation taking into consideration all ablation procedures	12 months
Secondary	Time required for successful linear ablation	Time required for successful linear ablation taking into consideration all ablation procedures	12 months
Secondary	Total fast anatomical mapping (FAM) time	Total FAM time taking into consideration all ablation procedures	12 months
Secondary	FAM volume	FAM volume of CFS vs non-CFS guided maps	12 months
Secondary	Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis	Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis	90 days
Secondary	Incidence of repeat ablation procedures		12 months
Secondary	Incidence of conduction gaps around pulmonary veins	Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps	12 months
Secondary	Freedom from atrial arrhythmia > 30 sec	Freedom from atrial arrhythmia > 30 sec at 12 months after one procedure	12 months
Secondary	Freedom from atrial arrhythmia > 30 sec after one or two procedures	Freedom from atrial arrhythmia > 30 sec at 12 months after one or two procedures	12 months
Secondary	Reduction in atrial arrhythmia burden by >90%		12 months