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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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Linear ablation is frequently used in the procedure for persistent atrial fibrillation. However, it has a limitation because of technical difficulty. Incomplete block is common and an important cause of atrial tachycardia.
The association between contact force values and successful linear block has not been revealed yet. We aim to the effectiveness and safety of linear ablation by using CF sensing catheter.
Catheter ablation is currently accepted as a treatment option for symptomatic atrial fibrillation. Linear ablation is frequently used in the procedure for persistent atrial fibrillation. Multiple studies have shown benefit of linear ablation. However, it has a limitation because of technical difficulty. Incomplete block is common and an important cause of atrial tachycardia.
Contact-force (CF) monitoring during procedure has recently been available. This technology appears to significantly decrease procedure time and short term reconnection incidence in pulmonary vein (PV) isolation. It also helped to resolve the cause of PV reconnection. Some reports demonstrated that the association between reconnection and lower CF value.
Linear ablation has more variation to interrupt block and reconnection was more often than PV isolation. The association between CF values and successful linear block has not been revealed yet. In addition, the investigators aim to the effectiveness and safety of linear ablation by using CF sensing catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contact force assisted linear ablation | Experimental | Left atrial linear ablation performed using the contact force sensing catheter after pulmonary vein isolation |
|
| control | Active Comparator | Left atrial linear ablation performed using the catheter without contact force sensing after pulmonary vein isolation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation | Procedure | A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation/atrial tachycardia | Freedom from any documented episode of atrial fibrillation/atrial tachycardia occurring after a single ablation procedure and lasting longer than 30 seconds with/without antiarrhythmic medication | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total radiofrequency energy | Total radiofrequency energy to achieve bidirectional block of linear lesion in left atrium | 12 months |
| Total force value | Total force value for complete block of linear lesion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung-Young Roh, MD | Contact | +82-10-3612-6876 | rsy008@gmail.com | |
| Kwang No Lee, MD | Contact | +82-10-9286-1123 | knlee81@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Medical Center Anam hospital | Recruiting | Seoul | 02841 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16302895 | Result | Fassini G, Riva S, Chiodelli R, Trevisi N, Berti M, Carbucicchio C, Maccabelli G, Giraldi F, Bella PD. Left mitral isthmus ablation associated with PV Isolation: long-term results of a prospective randomized study. J Cardiovasc Electrophysiol. 2005 Nov;16(11):1150-6. doi: 10.1111/j.1540-8167.2005.50192.x. | |
| 16344401 | 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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| Contact force assisted left atrial linear ablation | Procedure | Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation monitoring contact force. |
|
| left atrial linear ablation without contact force monitoring | Procedure | Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation without monitoring contact force. |
|
| 12 months |
| Hocini M, Jais P, Sanders P, Takahashi Y, Rotter M, Rostock T, Hsu LF, Sacher F, Reuter S, Clementy J, Haissaguerre M. Techniques, evaluation, and consequences of linear block at the left atrial roof in paroxysmal atrial fibrillation: a prospective randomized study. Circulation. 2005 Dec 13;112(24):3688-96. doi: 10.1161/CIRCULATIONAHA.105.541052. |
| 16782716 | Result | Willems S, Klemm H, Rostock T, Brandstrup B, Ventura R, Steven D, Risius T, Lutomsky B, Meinertz T. Substrate modification combined with pulmonary vein isolation improves outcome of catheter ablation in patients with persistent atrial fibrillation: a prospective randomized comparison. Eur Heart J. 2006 Dec;27(23):2871-8. doi: 10.1093/eurheartj/ehl093. Epub 2006 Jun 16. |
| 19808418 | Result | Gaita F, Caponi D, Scaglione M, Montefusco A, Corleto A, Di Monte F, Coin D, Di Donna P, Giustetto C. Long-term clinical results of 2 different ablation strategies in patients with paroxysmal and persistent atrial fibrillation. Circ Arrhythm Electrophysiol. 2008 Oct;1(4):269-75. doi: 10.1161/CIRCEP.108.774885. |
| 20817018 | Result | Santucci PA. Linear ablation of atrial fibrillation: what does it do? Heart Rhythm. 2010 Dec;7(12):1738-9. doi: 10.1016/j.hrthm.2010.09.001. Epub 2010 Sep 28. No abstract available. |
| 26041872 | Result | Kautzner J, Neuzil P, Lambert H, Peichl P, Petru J, Cihak R, Skoda J, Wichterle D, Wissner E, Yulzari A, Kuck KH. EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace. 2015 Aug;17(8):1229-35. doi: 10.1093/europace/euv057. Epub 2015 Jun 3. |
| 26260733 | Result | Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10. |
| 26272524 | Result | Andreu D, Gomez-Pulido F, Calvo M, Carlosena-Remirez A, Bisbal F, Borras R, Benito E, Guasch E, Prat-Gonzalez S, Perea RJ, Brugada J, Berruezo A, Mont L. Contact force threshold for permanent lesion formation in atrial fibrillation ablation: A cardiac magnetic resonance-based study to detect ablation gaps. Heart Rhythm. 2016 Jan;13(1):37-45. doi: 10.1016/j.hrthm.2015.08.010. Epub 2015 Aug 10. |
| 25618742 | Result | le Polain de Waroux JB, Weerasooriya R, Anvardeen K, Barbraud C, Marchandise S, De Meester C, Goesaert C, Reis I, Scavee C. Low contact force and force-time integral predict early recovery and dormant conduction revealed by adenosine after pulmonary vein isolation. Europace. 2015 Jun;17(6):877-83. doi: 10.1093/europace/euu329. Epub 2015 Jan 24. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |