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Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote magnetic navigation | Experimental | Persistent atrial fibrillation ablation with remote magnetic navigation |
|
| Cryoablation | Active Comparator | Persistent atrial fibrillation ablation with cryoballoon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote magnetic navigation | Procedure | Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy (time to first AF recurrence after blanking period) | the time to first AF recurrence after blanking period (month) | one year |
| Clinical safety (Any procedure-related complications) | Any procedure-related complications | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time (min) | one week | |
| Time to first cardiovascular hospitalization (month) | one year | |
| QoL of 12 months (Units on a Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qi Jin, MD | Ruijin Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27042964 | Result | 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. | |
| 27381589 | Result |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Cryoablation | Procedure | Pulmonary vein isolation and other areas ablation used by cryoballoon |
|
| one year |
| X-ray time (min) | one week |
| 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. |
| 27738068 | Result | 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. |
| 26969219 | Result | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |