Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
DEVICEVASCADE MVP VVCS
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.
Sponsors
Cardiva Medical, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age; 2. Underwent catheter-based ablation for atrial fibrillation with or without another arrythmia. 3. VASCADE MVP was the only closure device utilized. 4. Were discharged the same calendar day as the index procedure. 5. Completed a SOC follow-up \> 7 days post-procedure.
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from next day access site closure-related complications requiring hospital intervention | 1 day | Primary Performance Outcome |
| rate of major venous access site closure-related complications | ≥7 days | Major Complication rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from next day procedure-related complications requiring hospital intervention | 1 day | Secondary Performance Outcome |
| Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact | ≥7 days | Secondary Performance Outcome |
| minor venous access site closure-related complications | ≥7 days | Minor Complication rate |
Countries
United States
Outcome results
None listed