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It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.
The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cryoballoon ablation | Experimental | patients who accept cryoballoon ablation |
|
| radiofrequency ablation | Active Comparator | patients who accept radiofrequency ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryoballoon ablation | Procedure | cryoballoon ablation：pulmonary vein isolation by cryoballoon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint (time to first documented clinical recurrence after blanking period) | the time to first documented clinical recurrence after blanking period (month) | one year |
| Safety endpoint (Any procedure-related complications) | Any procedure-related complications | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time (min) | skin to skin | one year |
| Left atrial time (min) | one year | |
| X-ray time (min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Jin | Contact | jinqi127@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li-Qun Wu | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| 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. | |
| 24446022 | 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 |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| radiofrequency ablation | Procedure | radiofrequency ablation: pulmonary vein isolation by radiofrequency energy |
|
| one year |
| time to first time cardiovascular hospitalization (month) | one year |
| QoL changes at 12 months (Units on a Scale) | one year |
| Andrade JG, Khairy P, Macle L, Packer DL, Lehmann JW, Holcomb RG, Ruskin JN, Dubuc M. Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):69-75. doi: 10.1161/CIRCEP.113.000586. Epub 2014 Jan 19. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |