AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

• ClinicalTrials.gov Identifier: NCT04538781
• Recruitment Status: Completed
• First Posted: September 4, 2020
• Last Update Posted: March 1, 2021
• Sponsor: Cardiva Medical, Inc.
• Information provided by (Responsible Party): Cardiva Medical, Inc.

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
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: October 9, 2020
• Actual Primary Completion Date: January 11, 2021
• Actual Study Completion Date: February 8, 2021

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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)

Contacts and Locations

Locations

United States, California

Coastal Cardiology

San Luis Obispo, California, United States, 93401

United States, District of Columbia

MedStar Washington

Washington, District of Columbia, United States, 20010

United States, Massachusetts

Lahey Clinic

Burlington, Massachusetts, United States, 01805

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Cardiva Medical, Inc.

More Information

• Responsible Party: Cardiva Medical, Inc.
• ClinicalTrials.gov Identifier: NCT04538781
• Other Study ID Numbers: PTL 0617
• First Posted: September 4, 2020
• Last Update Posted: March 1, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes