AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: VASCADE MVP VVCS

• Registration Number: NCT04538781
• Lead Sponsor: Cardiva Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-04
• Study Start: 2020-10-09
• Status Verified: 2020-12
• Primary Completion: 2021-01-11
• Study Completion: 2021-02-08
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 497

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Same Day Discharge	VASCADE MVP VVCS	Patients undergoing a-fib ablation procedures who were closed with VASCADE MVP and were discharged the same day.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Freedom from next day procedure-related complications requiring hospital intervention	1 day	Secondary Performance Outcome

Trial Locations

Locations (4)

Coastal Cardiology; 🇺🇸 San Luis Obispo, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

MedStar Washington; 🇺🇸 Washington, District of Columbia, United States

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States