AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

Atrial Fibrillation Clinical Trial

Official title:

AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538781
• Other study ID #: PTL 0617
• Status: Completed
• Start date: October 9, 2020
• Est. completion date: February 8, 2021

Study information

• Verified date: December 2020
• Source: Cardiva Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: February 8, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Coastal Cardiology	San Luis Obispo	California
United States	MedStar Washington	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cardiva Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from next day access site closure-related complications requiring hospital intervention	Primary Performance Outcome	1 day
Primary	rate of major venous access site closure-related complications	Major Complication rate	=7 days
Secondary	Freedom from next day procedure-related complications requiring hospital intervention	Secondary Performance Outcome	1 day
Secondary	Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact	Secondary Performance Outcome	=7 days
Secondary	minor venous access site closure-related complications	Minor Complication rate	=7 days