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The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vision-MR Atrial Flutter Ablation | Experimental | Type 1 Atrial Flutter ablation performed in the iCMR with the Vision-MR Ablation Catheter 2.0 and associated Advantage-MR EP recorder and stimulator system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF Ablation | Device | RF ablation for type I atrial flutter under iCMR guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint: Bi-directional block confirmation | Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator & irrigation pump. | Time of procedure, following delivery of last ablation energy delivery point |
| Primary Safety Endpoint: Composite of serious cardiovascular adverse events | A composite of the following serious adverse events as adjudicated by an independent clinical events committee:
| 7-days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days | The percent of subjects free of documented type I atrial flutter recurrence | 3 months (90 days) |
| Chronic Safety Endpoint: all serious adverse event rate for duration of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kate Lindborg | Contact | 952-818-8400 | kate.lindborg@imricor.com | |
| Jennifer Somerville | Contact | 952-594-4138 | jennifer.somerville@imricor.com |
| Name | Affiliation | Role |
|---|---|---|
| Kate Lindborg | Imricor Medical Systems, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University (JHU) | Recruiting | Baltimore | Maryland | 21218 | United States |
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Rate of Serious Adverse Events during the clinical investigation as adjudicated by an independent clinical events committee
| 3 months (90 days) |
| University of Virginia (UVA) | Not yet recruiting | Charlottesville | Virginia | 22903 | United States |
|
| Virginia Commonwealth University | Not yet recruiting | Richmond | Virginia | 23284 | United States |
|
| l'institut Cardiologique Paris Sud (ICPS) | Recruiting | Massy | 91300 | France |
|
| Amsterdam University Medical Center (AUMC) | Recruiting | Amsterdam | Netherlands |
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| University Hospital of Vaud (CHUV) | Recruiting | Lausanne | 1011 | Switzerland |
|