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

Persistent Atrial Fibrillation Clinical Trial

— RECREATION  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03044925
• Other study ID #: 20161404
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Remote magnetic navigation
Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation
• Cryoablation
Pulmonary vein isolation and other areas ablation used by cryoballoon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

References & Publications (4)

Jin QI, Pehrson S, Jacobsen PK, Chen XU. Efficacy and Safety of Atrial Fibrillation Ablation Using Remote Magnetic Navigation: Experience from 1,006 Procedures. J Cardiovasc Electrophysiol. 2016 Mar;27 Suppl 1:S23-8. doi: 10.1111/jce.12929. — View Citation

Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9 — View Citation

Kuck KH, Fürnkranz A, Chun KR, Metzner A, Ouyang F, Schlüter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kühne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal a — View Citation

Kuniss M, Greiß H, Pajitnev D, Akkaya E, Deubner N, Hain A, Bodammer L, Berkowitsch A, Chierchia GB, Hamm CW, Neumann T. Cryoballoon ablation of persistent atrial fibrillation: feasibility and safety of left atrial roof ablation with generation of conduct — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy (time to first AF recurrence after blanking period)	the time to first AF recurrence after blanking period (month)	one year
Primary	Clinical safety (Any procedure-related complications)	Any procedure-related complications	one year
Secondary	Procedure time (min)		one week
Secondary	Time to first cardiovascular hospitalization (month)		one year
Secondary	QoL of 12 months (Units on a Scale)		one year
Secondary	X-ray time (min)		one week