N/A
N=168
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
Surgical Wound
Bottom Line
View on ClinicalTrials.gov: NCT03573206 ↗Enrolled (actual)
168
Serious AEs
1.8%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants With Overall Procedure Success - Effectiveness — 168 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardiva Medical, Inc.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Overall Procedure Success - Effectiveness |
168 | — |
| PRIMARY Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event |
— | — |
| SECONDARY Study Group Success Rate - No Urinary Catheter Group, Number of Participants |
161 | — |
| SECONDARY Study Group Success Rate - No Protamine Group, Number of Participants |
39 | — |
| SECONDARY Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants |
18 | — |
| SECONDARY Number of Devices With Success |
612 | — |
| SECONDARY Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event |
318 | — |
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.
Eligibility Criteria
Pre-Operative Inclusion Criteria:
- 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
Pre-Operative Exclusion Criteria:
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 12 Fr in inner diameter is present at time of closure;
- A procedural sheath > 12 Fr inner diameter at any time during the procedure.
- Venous access site location is noted to be "high", above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein);
- Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula;
- Length of the tissue tract, the distance between the anterior venous wall and skin, is estimated to be less than 2.5 cm.
Data sourced from ClinicalTrials.gov (NCT03573206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.