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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01851525
Other study ID # 01
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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