A Multi-center, Prospective, Single Arm Registry to Evaluate Procedural Outcomes Using the Cardiva VASCADE MVP VVCS Closure Device After Catheter-based Atrial Fibrillation Interventions for Patients Who Are Discharged the Same Day.

Cardiva Medical, Inc.15 sites in 1 country700 target enrollmentJune 30, 2020

ConditionsVascular Closure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vascular Closure
Sponsor: Cardiva Medical, Inc.
Enrollment: 700
Locations: 15
Primary Endpoint: VASCADE MVP VVCS Procedure Success
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A multi-center, prospective, single-arm post market registry, designed to collect both performance and complication outcomes when same day discharge is enabled by the study device, in sealing multiple femoral venous access sites at the completion of ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.

Registry

clinicaltrials.gov

Start Date

June 30, 2020

End Date

December 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cardiva Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pre-Operative Inclusion:
•All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
•≥18 years of age;
•Capable and willing to give informed consent;
•Acceptable candidate for an elective, non-emergent catheter-based paroxysmal atrial fibrillation ablation procedure with or without another arrhythmia via the common femoral vein(s) using a 6 to 12 Fr inner diameter (max 15F OD) introducer sheath
•Is accompanied by a person who will be available to assist the subject for 24 hours post-procedure and/or has access to emergency services;
•Is willing/able to stay overnight at the hospital per physician discretion.
•Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.
•Acceptable candidate for emergent vascular surgery, and/or manual compression of the venous access site;
•Intra-Operative Inclusion:

Exclusion Criteria

•Pre-Operative Exclusion:
•Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:
•Advanced refusal of blood transfusion, if it should become necessary;
•Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin;
•Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids;
•Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count \< 100,000 cells/mm3;
•Severe co-existing morbidities, with a life expectancy of less than 12 months;
•Currently involved in any clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
•Femoral arteriotomy in either limb with any of the following conditions:
•access within \< 10 days

Outcomes

Primary Outcomes

VASCADE MVP VVCS Procedure Success

Time Frame: 1 day

Patients do not require next day hospital intervention\* due to access site-related complications.

Major Complication Rate

Time Frame: 15 Days +/- 5 Days

On a per-limb basis, the rate of combined major venous access site closure-related complications attributed directly to the closure method within 15 ± 5 days of discharge (i.e., "device-related" with no other likely attributable cause).