Surgical Wound
Conditions
Keywords
vessel closure, venous access site, femoral venotomy, medium bore, multiple access sites
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.
Interventions
DEVICECardiva Mid-Bore Venous Vascular Closure Device (VVCS)
The device will be used to close all femoral venous access sites at the end of the case.
Sponsors
Cardiva Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will receive the study device for femoral venotomy closure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Procedure Success - Effectiveness | 30 (+/- 10) days post-procedure | Final hemostasis at all venous access sites and freedom from major venous access site closure-related complications through 30 days follow-up |
| Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event | 30 (+/- 10) days post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants | Within 72 hours post-discharge | Discharge within the same calendar day from the start of the procedure without the need for re-hospitalization within 72 hours of hospital discharge due to access site complications (per-patient analyses) |
| 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 | No peri-procedural urinary catheter insertion required through successful Ambulation (per-patient analyses) |
| Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 30 (+/- 10) days post-procedure | Rate of combined minor venous access site closure-related complications. The method used to determine what would be considered minor 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. |
| Number of Devices With Success | Evaluated for each access site immediately after device delivery is attempted, reported within 5 minutes of deployment | The ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per-access site analyses) |
| 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 | No delay in Ambulation due to access site bleeding in subjects who receive heparin but are not reversed with protamine (per-patient analyses) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Cardiva Medical Mid-Bore VVCS for venous femoral access site closure
Cardiva Mid-Bore Venous Vascular Closure Device (VVCS): The device will be used to close all femoral venous access sites at the end of the case. | 168 |
| Total | 168 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 11.7 |
| BMI (Body Mass Index) | 28.8 kg/m^2 STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 158 Participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 168 |
| other Total, other adverse events | 9 / 168 |
| serious Total, serious adverse events | 3 / 168 |
Outcome results
Primary
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.
Time frame: 30 (+/- 10) days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event | 0 Participants |
Primary
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
Time frame: 30 (+/- 10) days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Number of Participants With Overall Procedure Success - Effectiveness | 168 Participants |
Secondary
Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Rate of combined minor venous access site closure-related complications. The method used to determine what would be considered minor 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.
Time frame: 30 (+/- 10) days post-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Treatment Arm | Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 318 limbs |
Secondary
Number of Devices With Success
The ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per-access site analyses)
Time frame: Evaluated for each access site immediately after device delivery is attempted, reported within 5 minutes of deployment
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Treatment Arm | Number of Devices With Success | 612 devices |
Secondary
Study Group Success Rate - No Protamine Group, Number of Participants
No delay in Ambulation due to access site bleeding in subjects who receive heparin but are not reversed with protamine (per-patient analyses)
Time frame: From time of final hemostasis through successful ambulation, assessed to be within 6 hours of final hemostasis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Study Group Success Rate - No Protamine Group, Number of Participants | 39 Participants |
Secondary
Study Group Success Rate - No Urinary Catheter Group, Number of Participants
No peri-procedural urinary catheter insertion required through successful Ambulation (per-patient analyses)
Time frame: From start of procedure through successful ambulation, assessed to be within 6 hours of final hemostasis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Study Group Success Rate - No Urinary Catheter Group, Number of Participants | 161 Participants |
Secondary
Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants
Discharge within the same calendar day from the start of the procedure without the need for re-hospitalization within 72 hours of hospital discharge due to access site complications (per-patient analyses)
Time frame: Within 72 hours post-discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants | 18 Participants |