AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

Cardiva Medical, Inc.497 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

497

Conditions

Atrial Fibrillation

Interventions

VASCADE MVP VVCSDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (4)

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

Outcomes

Primary Outcomes

Freedom from next day access site closure-related complications requiring hospital intervention

Primary Performance Outcome

Time frame: 1 day

rate of major venous access site closure-related complications

Major Complication rate

Time frame: ≥7 days

Secondary Outcomes

Freedom from next day procedure-related complications requiring hospital intervention

Secondary Performance Outcome

Time frame: 1 day

Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact

Secondary Performance Outcome

Time frame: ≥7 days

minor venous access site closure-related complications

Minor Complication rate

Time frame: ≥7 days

Data from ClinicalTrials.gov

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