AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

Sponsor

Cardiva Medical, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04538781

Collaborator

(none)

497

Enrollment

Locations

Actual Duration (Months)

124.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: VASCADE MVP VVCS

Study Design

Study Type:

Observational

Actual Enrollment :

497 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

Actual Study Start Date :

Oct 9, 2020

Actual Primary Completion Date :

Jan 11, 2021

Actual Study Completion Date :

Feb 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Same Day Discharge Patients undergoing a-fib ablation procedures who were closed with VASCADE MVP and were discharged the same day.	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.

Arm

Intervention/Treatment

Same Day Discharge

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

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.

Outcome Measures

Primary Outcome Measures

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

Freedom from next day procedure-related complications requiring hospital intervention [1 day]
Secondary Performance Outcome
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥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.

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Cardiology	San Luis Obispo	California	United States	93401
2	MedStar Washington	Washington	District of Columbia	United States	20010
3	Lahey Clinic	Burlington	Massachusetts	United States	01805
4	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

Cardiva Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cardiva Medical, Inc.

ClinicalTrials.gov Identifier:

NCT04538781

Other Study ID Numbers:

PTL 0617

First Posted:

Sep 4, 2020

Last Update Posted:

Mar 1, 2021

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Mar 1, 2021