NCT04203329

AMBULATE Same Day Discharge Registry

A Multi-center, Prospective, Single Arm Registry to Evaluate Procedural Outcomes Using the Cardiva VASCADE MVP VVCS Closure Device After Catheter-based Atrial Fibrillation Interventions for Patients Who Are Discharged the Same Day.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Cardiva Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, prospective, single-arm post market registry, designed to collect both performance and complication outcomes when same day discharge is enabled by the study device, in sealing multiple femoral venous access sites at the completion of ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.

Conditions

• Vascular Closure

Interventions

Type	Name	Description
DEVICE	Femoral Venous Vascular Closure	Femoral venous vascular closure following catheter-based cardiac ablation a-fib cases utilizing 6-12 French inner diameter procedural sheaths at time of closure.

Timeline

• Start date: 2020-06-30
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-12-18
• Last updated: 2022-08-10

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study