AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

Completed

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04538781

Run by

Cardiva Medical, Inc.

People needed

497

Starts

2020-10-09

Expected to finish

2021-02-08

Last updated by the study team

2021-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age;
• Underwent catheter-based ablation for atrial fibrillation with or without another arrythmia.
• VASCADE MVP was the only closure device utilized.
• Were discharged the same calendar day as the index procedure.
• Completed a SOC follow-up > 7 days post-procedure.

You may not qualify if…

• 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)

Where it is running

• Coastal Cardiology — San Luis Obispo, California, United States
• MedStar Washington — Washington D.C., District of Columbia, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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