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This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions.
Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial fibrillation (AF).
The three main techniques described for ablation of persistent AF include pulmonary vein (PV) isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions.
The ideal endpoint of linear lesions should be complete electrical block; however, this is technically challenging, time consuming, and potentially hazardous. The ST catheter combined with 3D mapping and navigation software, gives physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure and will allow physicians to more safely and effectively treat atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| operator informed to contact force | Active Comparator | Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster) |
|
| operator blinded to contact force | Experimental | Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermocool Smart Touch Catheter | Device | Physician informed to contact force |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes) | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of primary endpoint (bidirectional conduction block at an anterior line) | Achievement of primary endpoint (bidirectional conduction block at an anterior line). Procedure Duration. Reduction of local potential amplitude during SR or atrial fibrillation after 60 seconds of ablation. Freedom of any atrial tachyarrhythmia at 7 day holter 3 and 6 months after a single ablation procedure. Freedom of any symptoms of atrial arrhythmias 6 months after ablation (except during blanking period of 6 weeks). Confirmation of gap-freeness in MRI (3-6 months after ablation). Quality of Life (atrial fibrillation symptom checklist und major depression index) pre, 3 and 6 months after Ablation. Safety (bleeding, pericardial effusion, thrombembolic events). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Estner, MD | Munich University Clinic, Campus Großhadern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Munich University Clinic, Campus Großhadern | Munich | Bavaria | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30320138 | Derived | Fichtner S, Wakili R, Rizas K, Siebermair J, Sinner MF, Wiktor T, Lackermair K, Schuessler F, Olesch L, Rainer S, Kaab S, Curta A, Kramer H, Estner HL. Benefit of Contact Force Sensing Catheter Technology for Successful Left Atrial Anterior Line Formation: A Prospective Randomized Trial. Biomed Res Int. 2018 Sep 18;2018:9784259. doi: 10.1155/2018/9784259. eCollection 2018. |
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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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| 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |