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A multi-center, retrospective, single arm post market registry to evaluate procedural outcomes data using the Cardiva VASCADE MVP Venous Vascular Closure System (VVCS) for the management of the femoral venotomy after catheter-based atrial fibrillation interventions with or without another arrythmia performed via 6-12F procedural sheaths with single or multiple access sites per limb for patients who are discharged the same day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same Day Discharge | Patients undergoing a-fib ablation procedures who were closed with VASCADE MVP and were discharged the same day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VASCADE MVP VVCS | Device | The VASCADE MVP Venous Vascular Closure System (VVCS) is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6 - 12F inner diameter (maximum 15F OD) procedural sheaths, with single or multiple access sites in one or both limbs. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from next day access site closure-related complications requiring hospital intervention | Primary Performance Outcome | 1 day |
| rate of major venous access site closure-related complications | Major Complication rate | ≥7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from next day procedure-related complications requiring hospital intervention | Secondary Performance Outcome | 1 day |
| Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact |
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Inclusion Criteria:
Exclusion Criteria:
1. Any additional procedure(s) involving femoral arterial or venous access in either limb within the SOC follow up period as defined by each site (minimum 7 days post-procedure)
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All subjects 1) treated for A-Fib with or without another arrythmia via catheter ablation 2) who received VASCADE MVP with no other vascular closure device and 3) were discharged the same calendar day during the retrospective date range.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Cardiology | San Luis Obispo | California | 93401 | United States | ||
| MedStar Washington |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
Secondary Performance Outcome |
| ≥7 days |
| minor venous access site closure-related complications | Minor Complication rate | ≥7 days |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |