Clinical trial NCT03044925: Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study)
Official title: Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation: A Prospective, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: persistent atrial fibrillation
remote magnetic navigation
cryoablation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical efficacy (time to first AF recurrence after blanking period)
timeFrame: one year
measure: Clinical safety (Any procedure-related complications)
timeFrame: one year
Secondary outcomes:
measure: Procedure time (min)
timeFrame: one week
measure: Time to first cardiovascular hospitalization (month)
timeFrame: one year
measure: QoL of 12 months (Units on a Scale)
timeFrame: one year
measure: X-ray time (min)
timeFrame: one week
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin Hospital
name: Qi Jin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuck KH, Brugada J, Furnkranz 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;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
citation: Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.
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 conduction block in addition to antral pulmonary vein isolation. Europace. 2017 Jul 1;19(7):1109-1115. doi: 10.1093/europace/euw146.
citation: 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.