Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study)
NCT ID: NCT03044925
Last Updated: 2019-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2016-11-01
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Remote magnetic navigation
Persistent atrial fibrillation ablation with remote magnetic navigation
Remote magnetic navigation
Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation
Cryoablation
Persistent atrial fibrillation ablation with cryoballoon
Cryoablation
Pulmonary vein isolation and other areas ablation used by cryoballoon
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Qi Jin
Clinical Professor
Principal Investigators
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Qi Jin, MD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
References
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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.
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.
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.
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.
Other Identifiers
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20161404
Identifier Type: -
Identifier Source: org_study_id
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