Clinical trial NCT03573206: AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
Official title: Multi-center, Single Arm Continued Access Protocol to Evaluate the Mid-Bore Venous VCS for the Management of the Femoral Venotomy After Catheter-based Interventions Via 6-12F Procedural Sheaths With Single or Multiple Access Sites Per Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Keywords: vessel closure
venous access site
femoral venotomy
medium bore
multiple access sites
Lead sponsor: Cardiva Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-29
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive the study device for femoral venotomy closure.
Primary purpose: TREATMENT

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.

Detailed description: A prospective multi-center, single arm continued access clinical protocol enrolling subjects with multiple femoral venous access sites. All femoral venous access sites will be closed using the Cardiva Mid-Bore VVCS. Subjects will be prospectively evaluated for eligibility in the three study groups in order to answer specific research questions related to safety and effectiveness of the device as it relates to the use of peri-procedural urinary catheters, protamine for reversal of heparin, and same calendar day discharge in a select group of procedure types.

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:

  1. No Urinary Catheter: Candidate to undergo the procedure and bedrest without a urinary catheter
  2. No Protamine: Candidate to receive procedural heparin for anti-coagulation management.
  3. 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:

1. Advanced refusal of blood transfusion, if it should become necessary;
2. Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin;
3. Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids;
4. Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count \< 100,000 cells/mm3;
5. Severe co-existing morbidities, with a life expectancy of less than 12 months;
6. Currently involved in any other investigational clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
7. Femoral arteriotomy in either limb with any of the following conditions:

   1. access within \< 10 days
   2. any residual hematoma, significant bruising, or known associated vascular complications
   3. use of a vascular closure device within the previous 30 days;
8. Femoral venotomy in either limb with any of the following conditions:

   1. access within \< 10 days
   2. any residual hematoma, significant bruising, or known associated vascular complications c use of a vascular closure device
9. Any planned procedure involving femoral arterial or venous access in either limb within the next 30 days;
10. Any history of deep vein thrombosis, pulmonary embolism or thrombophlebitis;
11. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
12. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or who are lactating;
13. Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
14. Unable to routinely walk at least 20 feet without assistance;
15. Known allergy/adverse reaction to bovine derivatives;
16. Administration of low molecular weight heparin (LMWH) within 8 hours before or after the procedure;
17. Planned procedures or concomitant condition(s) that may extend ambulation attempts beyond 2-3 hours, and/or hospitalization time (e.g., staged procedure, serious co-morbidity), in the opinion of the Investigator.

Intra-Operative Inclusion Criteria:

The subject must be eligible for at least one of the following study groups:

1. Same Calendar Day Discharge (all criteria apply):

   * In the Investigator's opinion, the subject is a candidate for Same Calendar Day Discharge per protocol.
   * If procedural heparin is used, it must be reversed at or before venous closure.
   * Physician must be on site for discharge evaluation.
   * Supraventricular Tachycardia (SVT) or Atrial Flutter Subjects: No Additional Criteria
   * Atrial Fibrillation or Ventricular Tachycardia Procedure Subjects: CHADS2 Score is ≤1, as assessed pre-operatively.

     * The subject is not enrolled in the No Protamine Group.
2. No Urinary Catheter:

   • The subject does not have a urinary catheter inserted/indwelling at the end of the procedure, just prior to enrollment.
3. No Protamine:

   * The subject received procedural heparin for anti-coagulation management and did not/will not receive protamine.
   * The subject is not enrolled in the Same Calendar Day Discharge Group

Intra-Operative Exclusion Criteria:

Subjects will be excluded from participating in this study if any of the following exclusion criteria occur during the index procedure:

1. Any attempt at femoral arterial access during the procedure;
2. Any procedural complications that may extend routine recovery, ambulation and discharge times;
3. If the physician deems that a different method should be used to achieve hemostasis of the venous access sites, or that the subject should not attempt ambulation according to the protocol requirements;
4. All venous access sites may must comply with the following exclusion criteria, assessed immediately prior to enrollment:

   1. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.) in any of the study veins;
   2. A procedural sheath \< 6 Fr or \> 12 Fr in inner diameter is present at time of closure;
   3. A procedural sheath \> 12 Fr inner diameter at any time during the procedure.
   4. 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);
   5. Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula;
   6. Length of the tissue tract, the distance between the anterior venous wall and skin, is estimated to be less than 2.5 cm.

Primary outcomes:
measure: Number of Participants With Overall Procedure Success - Effectiveness
timeFrame: 30 (+/- 10) days post-procedure
measure: Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event
timeFrame: 30 (+/- 10) days post-procedure
Secondary outcomes:
measure: Study Group Success Rate - No Urinary Catheter Group, Number of Participants
timeFrame: From start of procedure through successful ambulation, assessed to be within 6 hours of final hemostasis
measure: Study Group Success Rate - No Protamine Group, Number of Participants
timeFrame: From time of final hemostasis through successful ambulation, assessed to be within 6 hours of final hemostasis
measure: Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants
timeFrame: Within 72 hours post-discharge
measure: Number of Devices With Success
timeFrame: Evaluated for each access site immediately after device delivery is attempted, reported within 5 minutes of deployment
measure: Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event
timeFrame: 30 (+/- 10) days post-procedure
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Amin M Al-Ahmad, MD
role: PRINCIPAL_INVESTIGATOR
References: