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The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Randomized | Experimental | All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vision-MR Ablation Catheter 2.0 | Device | Catheter ablation of ventricular tachycardia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint | Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0 | Perioperative/Periprocedural |
| Primary Safety Endpoint | Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy Endpoint | Chronic success defined as 6-month freedom from recurrence of sustained VT or VT requiring intervention and freedom from new or increased dose of Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kate Lindborg, Phd | Contact | 9528188400 | kate.lindborg@imricor.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Leipzig | Not yet recruiting | Leipzig | Saxony | 04289 | Germany |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
|
| HagaZiekenhuis | Not yet recruiting | The Hague | 2545 AA | Netherlands |
|
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |