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The goal of this study is to determine the safety and performance of a new guidewire and pacing system called the Fusion System in treating patients undergoing transcatheter aortic valve replacement (TAVR) or similar procedures. The main questions it aims to answer are:
Is the Fusion System safe? Is the Fusion System's clinical performance acceptable?
Participants will asked to sign a study consent and report any adverse events experienced until they are discharged from hospital (or a maximum of 2 days following their procedure).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fusion System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortic valve repair/replacement | Device | TAVR or valvuloplasty using the Fusion System for delivery of the treatment system and for temporary rapid pacing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transcatheter heart valve device migration/embolization or inability to complete BAV procedure. | Incidence of failure of the Solo Pace Fusion System to provide adequate pacing leading to transcatheter heart valve device migration/embolization or the inability to complete the BAV procedure | Intraprocedure |
| Successful deployment of THV or BAV system over the Fusion Guidewire | The Primary Performance Endpoint for the study consists of the following criteria (note: both criteria must be met):
| Intraprocedure |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012092 | Replantation |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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