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The goal of this study is to compare OTW balloon with microcatheter in the Marshall vein alcohol ablation study. The main questions it aims to answer are: • Is there a difference in the effectiveness and safety of OTW balloon and microcatheter in Marshall vein alcohol ablation? Participants will be asked to:
Undergo treatment with OTW balloon Undergo treatment with microcatheter If there is a comparison group: Researchers will compare the OTW balloon group and the microcatheter group to see different effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTW group | Placebo Comparator |
| |
| Microcatheter group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microcatheter | Device | The microcatheter group undergoes alcohol ablation using a microcatheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute rate of mitral isthmus block | Efficacy endpoints | During catheter ablation procedures |
| Procedural complications | Safety endpoints | During catheter ablation procedures |
| Recovery rate of the mitral isthmus line | Long-term primary efficacy endpoints | beyond 3 months after the ablation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural characteristics | Periprocedural period | |
| Hospitalization costs | Periprocedural period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Liu, MD | Contact | +8618101817225 | drliuxu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong University of Traditional Chinese Medicine | Jinan | Shandong | 250000 | China |
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| OTW | Device | The OTW group undergoes alcohol ablation using an OTW balloon. |
|
| Ren Ji Hospital | Shanghai | Shanghai Municipality | 200030 | China |
|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
|
| Yuhuan Second People's Hospital | Taizhou | Zhejiang | 318000 | China |
|
| Changshu Hospital of Traditional Chinese Medical | Changshu | 215500 | China |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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