AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: VASCADE MVP VVCS

• Study Type: Observational
• Enrollment (Actual): 497

Contacts and Locations

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93401
      • Coastal Cardiology
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All subjects 1) treated for A-Fib with or without another arrythmia via catheter ablation 2) who received VASCADE MVP with no other vascular closure device and 3) were discharged the same calendar day during the retrospective date range.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from next day access site closure-related complications requiring hospital intervention	Primary Performance Outcome	1 day
rate of major venous access site closure-related complications	Major Complication rate	≥7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from next day procedure-related complications requiring hospital intervention	Secondary Performance Outcome	1 day
Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact	Secondary Performance Outcome	≥7 days
minor venous access site closure-related complications	Minor Complication rate	≥7 days

Collaborators and Investigators

• Sponsor: Cardiva Medical, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2020
• Primary Completion (ACTUAL): January 11, 2021
• Study Completion (ACTUAL): February 8, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (ACTUAL): September 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PTL 0617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No