AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)

NCT03573206 | Completed Results FDA Device

• 1 other identifier: PTL-0543
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures performed through 6-12 Fr introducer sheath, while allowing for one or more of the following: elimination of the Foley catheter, elimination of protamine, or allowing same (calendar) day discharge for the appropriate patient population.

Conditions

Surgical Wound

Keywords

vessel closure; venous access site; femoral venotomy; medium bore; multiple access sites

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Overall Procedure Success - Effectiveness

  Final hemostasis at all venous access sites and freedom from major venous access site closure-related complications through 30 days follow-up

  30 (+/- 10) days post-procedure

• Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event

  Rate of combined major venous access site closure-related complications. The method used to determine what would be considered "major" venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.

  30 (+/- 10) days post-procedure

Secondary Outcomes (5)

• Study Group Success Rate - No Urinary Catheter Group, Number of Participants

  From start of procedure through successful ambulation, assessed to be within 6 hours of final hemostasis

• Study Group Success Rate - No Protamine Group, Number of Participants

  From time of final hemostasis through successful ambulation, assessed to be within 6 hours of final hemostasis

• Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants

  Within 72 hours post-discharge

• Number of Devices With Success

  Evaluated for each access site immediately after device delivery is attempted, reported within 5 minutes of deployment

• Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event

  30 (+/- 10) days post-procedure

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Cardiva Medical Mid-Bore VVCS for venous femoral access site closure

Device: Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)

Interventions

Cardiva Mid-Bore Venous Vascular Closure Device (VVCS) DEVICE

The device will be used to close all femoral venous access sites at the end of the case.

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Acceptable candidate for an elective, non-emergent catheter-based procedure via the common femoral vein(s) using a 6 to 12 Fr inner diameter introducer sheath
• Must be eligible for at least one of the study groups:
• No Urinary Catheter: Candidate to undergo the procedure and bedrest without a urinary catheter
• No Protamine: Candidate to receive procedural heparin for anti-coagulation management.
• Same Calendar Day Discharge: Expected to undergo a procedure for Supraventricular Tachycardia, Atrial Flutter, Atrial Fibrillation or Ventricular Tachycardia; if heparin is planned, it must be reversed with protamine; and physician is expected to be on site for discharge evaluation

You may not qualify if:

• 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 other investigational 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
• any residual hematoma, significant bruising, or known associated vascular complications
• use of a vascular closure device within the previous 30 days;
• Femoral venotomy in either limb with any of the following conditions:
• access within \< 10 days
• any residual hematoma, significant bruising, or known associated vascular complications c use of a vascular closure device
• Any planned procedure involving femoral arterial or venous access in either limb within the next 30 days;

Sponsors & Collaborators

• Cardiva Medical, Inc.: lead

Study Sites (3)

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Terry Alverson, Director of Regulatory and Clinical
• Organization: Cardiva Medical

Terry_Alverson@cardivamedical.com

650-207-0563

Study Officials

• Amin M Al-Ahmad, MD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will receive the study device for femoral venotomy closure.

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 29, 2018
• Study Start: August 27, 2018
• Primary Completion: January 14, 2019
• Study Completion: March 31, 2019
• Last Updated: March 10, 2023
• Results First Posted: February 5, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)