AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry

NCT04538781 | Completed FDA Device

• 1 other identifier: PTL 0617
• Study Type: observational
• Target: 497
• Locations: 1 country
• Sites: 4

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Freedom from next day procedure-related complications requiring hospital intervention

  1 day

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

  ≥7 days

• minor venous access site closure-related complications

  ≥7 days

Study Arms (1)

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

Interventions

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.

Same Day Discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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.

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Cardiva Medical, Inc.: lead

Study Sites (4)

Coastal Cardiology

San Luis Obispo, California, 93401, United States

Location

MedStar Washington

Washington D.C., District of Columbia, 20010, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 4, 2020
• Study Start: October 9, 2020
• Primary Completion: January 11, 2021
• Study Completion: February 8, 2021
• Last Updated: March 1, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)