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The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocardial Ablation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocardial Ablation | Procedure |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Safety | Incidence of early onset (within 7 days of ablation procedure) primary AEs | 7 Days |
| Acute performance | Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application) | This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Incidence of Serious Adverse Events during follow-up | Until one-month follow-up |
| Acute Efficacy | Right atrial flutter recurrence within 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Grimaldi | Miulli Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Within 30 Days |
| Procedural data | Ablation parameters, including:
| During Procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |