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To compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.
This is a single centre, prospective control study. The study will enroll 180 patients with 2:1 grouped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVAM | Experimental | pulomonary vein antrum modification with contact force monitoring for AF |
|
| Control arm | Active Comparator | pulmonary vein isolation without contact force |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulmonary vein antrum modification | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| any recorded atrial arrhythmias proved by 7-day holter | sustained at least 30s | at least 18 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| procedure time | time that the patient spend in the procedure room | time during patient enrollment |
| x ray time | x ray spent during the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23515263 | Result | Neuzil P, Reddy VY, Kautzner J, Petru J, Wichterle D, Shah D, Lambert H, Yulzari A, Wissner E, Kuck KH. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):327-33. doi: 10.1161/CIRCEP.113.000374. Epub 2013 Mar 20. | |
| 22820056 |
| Label | URL |
|---|---|
| an article about the contact force role in ablation for AF | View source |
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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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| time during patient enrollment |
| adverse event | at least 18 months follow up |
| Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |