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NCT03573206 · ClinicalTrials.gov registry record · NA
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
A NA study of Surgical Wound, sponsored by Cardiva Medical.
- Completed
- Registry status
- NA
- Development phase
- 168
- Enrollment target
- 3
- Study locations
NCT03573206: Completed NA study of Surgical Wound, sponsored by Cardiva Medical.
NCT03573206 is a NA study of Surgical Wound that has completed, run by Cardiva Medical. The registered enrollment target is 168 participants, above the 86-participant average among 17 other Surgical Wound trials with a reported enrollment target (95% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03573206, a NA study of Surgical Wound, has completed, sponsored by Cardiva Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 168 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Final hemostasis at all venous access sites and freedom from major venous access site closure-related complications through 30 days follow-up
Conditions Studied
Interventions
- DEVICE Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
Study Locations (3)
Georgia
- Emory St. Joseph's Hospital - Atlanta
New Jersey
- Valley Hospital - Ridgewood
Texas
- Texas Cardiac Arrhythmia Research Foundation - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2018-08-27 |
| Est. Completion | 2019-03-31 |
| Phase | NA |
What the finished NCT03573206 record still lists
NCT03573206 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 86-participant average among 17 other Surgical Wound trials with a reported enrollment target (95% higher).
The record links to 1 condition, with Surgical Wound appearing as the primary indexed condition, and to 1 intervention - of which Cardiva Mid-Bore Venous Vascular Closure Device (VVCS) is the first listed.
NCT03573206 reports a single indexed study location in Georgia, New Jersey, Texas.
Frequently Asked Questions
What is clinical trial NCT03573206 about?
NCT03573206 is a clinical study titled "AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)". 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...
What is the current status of trial NCT03573206?
This trial is currently completed. It is a NA study. The enrollment target is 168 participants. The study started on 2018-08-27. Estimated completion is 2019-03-31.
What conditions does trial NCT03573206 study?
This clinical trial studies the following conditions: Surgical Wound.
What interventions are being tested in trial NCT03573206?
The interventions under investigation include: Cardiva Mid-Bore Venous Vascular Closure Device (VVCS) (DEVICE).
Who is sponsoring clinical trial NCT03573206?
This trial is sponsored by Cardiva Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03573206 being conducted?
This trial has 3 study locations across Georgia, New Jersey, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgical Wound
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03573206's enrollment target sits among peer trials
168 3rd of 17 higher than 15 of 17 other Surgical Wound trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Wound trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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