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

Not Applicable

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Remote magnetic navigation; Procedure: Cryoablation

• Registration Number: NCT03044925
• Lead Sponsor: Ruijin Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-06
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote magnetic navigation	Remote magnetic navigation	Persistent atrial fibrillation ablation with remote magnetic navigation
Cryoablation	Cryoablation	Persistent atrial fibrillation ablation with cryoballoon

Primary Outcome Measures

Name	Time	Method
Clinical efficacy (time to first AF recurrence after blanking period)	one year	the time to first AF recurrence after blanking period (month)
Clinical safety (Any procedure-related complications)	one year	Any procedure-related complications

Secondary Outcome Measures

Name	Time	Method
QoL of 12 months (Units on a Scale)	one year
Procedure time (min)	one week
Time to first cardiovascular hospitalization (month)	one year
X-ray time (min)	one week