Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study) (RECREATION)
Primary Purpose
Persistent Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote magnetic navigation
Cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring persistent atrial fibrillation, remote magnetic navigation, cryoablation
Eligibility Criteria
Inclusion Criteria:
- Persistent atrial fibrillation (>7d, < 5years)
- Age 18-75 years
- 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:
- Any previous left atrial ablation or surgery
- Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment
- Stroke or transient ischemic attack within 6 months prior to enrollment
- Myocardial infarction within 3 months prior to enrollment
- Anteroposterior left atrial diameter > 55 mm
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remote magnetic navigation
Cryoablation
Arm Description
Persistent atrial fibrillation ablation with remote magnetic navigation
Persistent atrial fibrillation ablation with cryoballoon
Outcomes
Primary Outcome Measures
Clinical efficacy (time to first AF recurrence after blanking period)
the time to first AF recurrence after blanking period (month)
Clinical safety (Any procedure-related complications)
Any procedure-related complications
Secondary Outcome Measures
Procedure time (min)
Time to first cardiovascular hospitalization (month)
QoL of 12 months (Units on a Scale)
X-ray time (min)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03044925
Brief Title
Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study)
Acronym
RECREATION
Official Title
Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation: A Prospective, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
Detailed Description
Compare the efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
Compare the safety of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
Compare the procedural parameters of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
Compare the effects of amiodarone on recurrence after these two different ablation procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
persistent atrial fibrillation, remote magnetic navigation, cryoablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remote magnetic navigation
Arm Type
Experimental
Arm Description
Persistent atrial fibrillation ablation with remote magnetic navigation
Arm Title
Cryoablation
Arm Type
Active Comparator
Arm Description
Persistent atrial fibrillation ablation with cryoballoon
Intervention Type
Procedure
Intervention Name(s)
Remote magnetic navigation
Intervention Description
Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Intervention Description
Pulmonary vein isolation and other areas ablation used by cryoballoon
Primary Outcome Measure Information:
Title
Clinical efficacy (time to first AF recurrence after blanking period)
Description
the time to first AF recurrence after blanking period (month)
Time Frame
one year
Title
Clinical safety (Any procedure-related complications)
Description
Any procedure-related complications
Time Frame
one year
Secondary Outcome Measure Information:
Title
Procedure time (min)
Time Frame
one week
Title
Time to first cardiovascular hospitalization (month)
Time Frame
one year
Title
QoL of 12 months (Units on a Scale)
Time Frame
one year
Title
X-ray time (min)
Time Frame
one week
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persistent atrial fibrillation (>7d, < 5years)
Age 18-75 years
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:
Any previous left atrial ablation or surgery
Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment
Stroke or transient ischemic attack within 6 months prior to enrollment
Myocardial infarction within 3 months prior to enrollment
Anteroposterior left atrial diameter > 55 mm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Jin, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27042964
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.
Results Reference
result
PubMed Identifier
27381589
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.
Results Reference
result
PubMed Identifier
27738068
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.
Results Reference
result
PubMed Identifier
26969219
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.
Results Reference
result
Learn more about this trial
Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation (RECREATION Study)
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