Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study)

Study Overview
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Brief Summary
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Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.

Detailed Description
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Compare the efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. Compare the safety of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. Compare the procedural parameters of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. Compare the effects of amiodarone on recurrence after these two different ablation procedures.

Official Title
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Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation: A Prospective, Controlled Study

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Remote magnetic navigation
* Procedure: Cryoablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent atrial fibrillation (>7d, < 5years) Age 18-75 years Patient is mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol Exclusion Criteria: Any previous left atrial ablation or surgery Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment Stroke or transient ischemic attack within 6 months prior to enrollment Myocardial infarction within 3 months prior to enrollment Anteroposterior left atrial diameter > 55 mm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote magnetic navigation<br>Persistent atrial fibrillation ablation with remote magnetic navigation | Procedure: Remote magnetic navigation<br>* Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation<br>|
| Active Comparator: Cryoablation<br>Persistent atrial fibrillation ablation with cryoballoon | Procedure: Cryoablation<br>* Pulmonary vein isolation and other areas ablation used by cryoballoon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy (time to first AF recurrence after blanking period) | the time to first AF recurrence after blanking period (month) | one year | 
| Clinical safety (Any procedure-related complications) | Any procedure-related complications | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time (min) |  | one week | 
| Time to first cardiovascular hospitalization (month) |  | one year | 
| QoL of 12 months (Units on a Scale) |  | one year | 
| X-ray time (min) |  | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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persistent atrial fibrillation, remote magnetic navigation, cryoablation