An interventional study of Cardiva Mid-Bore VVCS and Manual compression in Surgical Wound, sponsored by Cardiva Medical, Inc.. Completed at 13 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by Cardiva Medical, Inc. · Not applicable, Interventional, and Treatment
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 and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
Only patients with multiple access sites will be enrolled in order to support the desired indication. Randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.
519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.
This study's enrollment of 204 is above the median of 80 across 412 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Cardiva Medical, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.
Device: Cardiva Mid-Bore VVCS
Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.
Other: Manual compression
The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.
Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Time to Ambulation (TTA)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.
Time frame: Post-procedure, usually within 6 hours
Major Venous Access Site Closure-related Complications, 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 +/- 7 days post-procedure
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 +/- 7 days post-procedure
Time to Discharge Eligibility (TTDE)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is eligible for discharge based solely on assessment of the access site
Time frame: Prior to hospital discharge, usually within 24 hours
Time to Hemostasis (TTH)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and first observed and confirmed venous hemostasis, for each access site.
Time frame: Post-procedure, usually within 3 hours
Time to Discharge (TTD)
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is discharged
Time frame: Prior to hospital discharge, usually within 24 hours
Time to Closure Eligibility (TTCE)
Elapsed time between removal of the last procedural device for the index procedure and removal of the first Mid-Bore VVCS device (treatment arm) or removal of first sheath (control arm)
Time frame: Post-procedure, usually within 6 hours
Total Post-Procedure Time (TPPT)
Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate
Time frame: Post-procedure, usually within 6 hours
Number of Participants With Procedure Success
Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
Time frame: 30 +/- 7 days post-procedure
Number of Access Sites With Device Success
Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)
Time frame: Procedural, usually within 15 minutes of enrollment
| Milestone | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Started | 100 | 104 |
| Completed | 99 | 103 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.
| hours | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Time to Ambulation (TTA) | 2.8 ± 1.3 | 6.1 ± 1.6 |
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.
| major complications | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 0 (-0.02 to 0.04) | 0 (-0.02 to 0.04) |
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.
| minor complications | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 2 | 5 |
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is eligible for discharge based solely on assessment of the access site
| hours | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Time to Discharge Eligibility (TTDE) | 3.1 ± 1.3 | 6.5 ± 1.9 |
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and first observed and confirmed venous hemostasis, for each access site.
| minutes | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Time to Hemostasis (TTH) | 6.1 ± 3.7 | 13.7 ± 6.5 |
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is discharged
| hours | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Time to Discharge (TTD) | 21.8 ± 13.4 | 21.8 ± 9.5 |
Elapsed time between removal of the last procedural device for the index procedure and removal of the first Mid-Bore VVCS device (treatment arm) or removal of first sheath (control arm)
| minutes | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Time to Closure Eligibility (TTCE) | 10.5 ± 6.0 | 37.6 ± 33.2 |
Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate
| hours | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Total Post-Procedure Time (TPPT) | 3.1 ± 1.3 | 6.8 ± 1.7 |
Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
| Participants | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| Study Subjects | 98 | 103 |
| LTF | 2 | 1 |
Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)
| Successful Femoral Access Sites | Cardiva Mid-Bore VVCS |
|---|---|
| Number of Access Sites With Device Success | 351 |
Collected over 30 days (± 7 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cardiva Mid-Bore VVCS | 0/100 (0%) | 9/100 (9%) | 0/100 (0%) |
| Manual Compression | 0/104 (0%) | 2/104 (1.9%) | 0/104 (0%) |
| Event | Cardiva Mid-Bore VVCS | Manual Compression |
|---|---|---|
| POST ABLATION -SVT/ AFLUTTERCardiac disorders | 1/100 | 0/104 |
| ACUTE KIDNEY INSUFFICIENCYRenal and urinary disorders | 1/100 | 0/104 |
| ACUTE DIASTOLIC HEART FAILURE EXACERBATIONCardiac disorders | 1/100 | 0/104 |
| Arterial Perforation - non-access site-relatedCardiac disorders | 1/100 | 0/104 |
| CHEST PAINCardiac disorders | 1/100 | 0/104 |
| FLUID OVERLOADSurgical and medical procedures | 1/100 | 0/104 |
| HYPOTENSIONCardiac disorders | 1/100 | 0/104 |
| NEW ONSET A-FLUTTERCardiac disorders | 1/100 | 0/104 |
| PERICARDIAL EFFUSIONCardiac disorders | 1/100 | 0/104 |
| PNEUMONIAInfections and infestations | 1/100 | 0/104 |
| Age, Continuous(years) | Cardiva Mid-Bore VVCS | Manual Compression | Total |
|---|---|---|---|
| Mean | 61.5 ± 11.6 | 63.4 ± 11.1 | 62.5 ± 11.3 |
| Sex: Female, Male(Participants) | Cardiva Mid-Bore VVCS | Manual Compression | Total |
|---|---|---|---|
| Female | 33 | 40 | 73 |
| Male | 67 | 64 | 131 |
| Ethnicity (NIH/OMB)(Participants) | Cardiva Mid-Bore VVCS | Manual Compression | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 6 | 9 |
| Not Hispanic or Latino | 97 | 95 | 192 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Race (NIH/OMB)(Participants) | Cardiva Mid-Bore VVCS | Manual Compression | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 0 | 3 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 10 |
| White | 86 | 93 | 179 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 6 | 9 |
| Region of Enrollment(participants) | Cardiva Mid-Bore VVCS | Manual Compression | Total |
|---|---|---|---|
| United States | 100 | 104 | 204 |
| BMI(kg/m^2) | Cardiva Mid-Bore VVCS | Manual Compression | Total |
|---|---|---|---|
| Mean | 29.5 ± 4.5 | 29.7 ± 5.2 | 29.6 ± 4.9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cardiva Medical, Inc.