Skip to main content
OpenTrials
Completed

NCT Number: NCT04538781

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coastal Cardiology, San Luis Obispo, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VASCADE MVP VVCS

Device

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.

Primary outcomes

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

    Time frame: 1 day

    Primary Performance Outcome

  2. rate of major venous access site closure-related complications

    Time frame: ≥7 days

    Major Complication rate

Secondary outcomes

  1. Freedom from next day procedure-related complications requiring hospital intervention

    Time frame: 1 day

    Secondary Performance Outcome

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

    Time frame: ≥7 days

    Secondary Performance Outcome

  3. minor venous access site closure-related complications

    Time frame: ≥7 days

    Minor Complication rate

Sponsors and collaborators

Lead sponsor

Cardiva Medical, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2020
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.