AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

Cardiva Medical

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: VASCADE MVP VVCS

Study type: Observational

Funder types: Industry

Identifiers

NCT04538781

PTL 0617

Details and patient eligibility

About

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.

Enrollment: 497 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

497 participants in 1 patient group

Same Day Discharge

Description:

Patients undergoing a-fib ablation procedures who were closed with VASCADE MVP and were discharged the same day.

Treatment:

Device: VASCADE MVP VVCS