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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Cryoablation; Procedure: Remote magnetic navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03044925

20161404

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Remote magnetic navigation

Experimental group

Description:

Persistent atrial fibrillation ablation with remote magnetic navigation

Treatment:

Procedure: Remote magnetic navigation

Cryoablation

Active Comparator group

Description:

Persistent atrial fibrillation ablation with cryoballoon

Treatment:

Procedure: Cryoablation