CompletedNot Applicable

AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)

United States168 participantsStarted 2018-08-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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 \< 100,000 cells/mm3;
✕. Severe co-existing morbidities, with a life expectancy of less than 12 months;
✕. Currently involved in any other investigational clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
✕. Femoral arteriotomy in either limb with any of the following conditions:
✕. access within \< 10 days

What they're measuring

Number of Participants With Overall Procedure Success - Effectiveness

Timeframe: 30 (+/- 10) days post-procedure

Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event

Timeframe: 30 (+/- 10) days post-procedure

Trial details

NCT IDNCT03573206

SponsorCardiva Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-14

Results submitted2020-01-06

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