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

Ruijin Hospital200 enrolled

Overview

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

1. Compare the efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. 2. Compare the safety of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. 3. Compare the procedural parameters of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. 4. Compare the effects of amiodarone on recurrence after these two different ablation procedures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Persistent Atrial Fibrillation

Interventions

Remote magnetic navigationPROCEDURE

Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation

CryoablationPROCEDURE

Pulmonary vein isolation and other areas ablation used by cryoballoon

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Persistent atrial fibrillation (\>7d, \< 5years) 2. Age 18-75 years 3. 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: 1. Any previous left atrial ablation or surgery 2. Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment 3. Stroke or transient ischemic attack within 6 months prior to enrollment 4. Myocardial infarction within 3 months prior to enrollment 5. Anteroposterior left atrial diameter \> 55 mm

Outcomes

Primary Outcomes

Clinical efficacy (time to first AF recurrence after blanking period)

the time to first AF recurrence after blanking period (month)

Time frame: one year

Clinical safety (Any procedure-related complications)

Any procedure-related complications

Time frame: one year

Secondary Outcomes

Procedure time (min)

Time frame: one week

Time to first cardiovascular hospitalization (month)

Time frame: one year

QoL of 12 months (Units on a Scale)

Time frame: one year

X-ray time (min)

Time frame: one week

Data from ClinicalTrials.gov

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