Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

Study Overview
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Brief Summary
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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: guided by contact force sensing (CFS) OR blinded to contact force sensing (CFS) - i.e. standard approach

Official Title
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Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Contact Force Sensing (CFS) Blinded<br>Contact Force Sensing (CFS) Blinded: Operator will be blinded to data provided by the integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter) | Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster<br> <br> |
| Active Comparator: Contact Force Sensing (CFS) Guided<br>Contact Force Sensing (CFS) Guided: Operator will be guided by integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter) | Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from AF or atrial arrhythmia >30 sec | Freedom from AF or atrial arrhythmia >30 sec at 12 months post-initial ablation | 12 months | 
| 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 | 
| 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 | 
| 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 | 
| Number & location of conduction gaps after initial linear ablation | Number & location of conduction gaps after initial linear ablation during first ablation procedure | 6 hours | 
| Time required for successful PV isolation | Time required for successful PV isolation taking into consideration all ablation procedures | 12 months | 
| Time required for successful linear ablation | Time required for successful linear ablation taking into consideration all ablation procedures | 12 months | 
| Total fast anatomical mapping (FAM) time | Total FAM time taking into consideration all ablation procedures | 12 months | 
| FAM volume | FAM volume of CFS vs non-CFS guided maps | 12 months | 
| 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 | 
| Incidence of repeat ablation procedures |  | 12 months | 
| Incidence of conduction gaps around pulmonary veins | Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps | 12 months | 
| Freedom from atrial arrhythmia > 30 sec | Freedom from atrial arrhythmia > 30 sec at 12 months after one procedure | 12 months | 
| 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 | 
| Reduction in atrial arrhythmia burden by >90% |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Ablation