NCT04538781

AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 497 (actual)
• Sponsor: Cardiva Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	VASCADE 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.

Timeline

• Start date: 2020-10-09
• Primary completion: 2021-01-11
• Completion: 2021-02-08
• First posted: 2020-09-04
• Last updated: 2021-03-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study