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Suture Closure Methods for Cardiac Procedures (SAFE-VEIN Trial)
SAFE-VEIN Trial Summary
This trial is testing whether a venous closure device is more effective than conventional methods in terms of time to hemostasis, time to ambulation, and time to discharge.
- Pulmonary Embolism
- Sinus Node Dysfunction or Sick Sinus Syndrome
- Bradycardia-Tachycardia Syndrome
- Atrial Flutter
- Atrial Fibrillation
- Slow Heart Rate
- Heart Block
- Mitral Valve Repair
SAFE-VEIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSAFE-VEIN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SAFE-VEIN Trial Design
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Who is running the clinical trial?
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- You can't walk at least 20 feet without help.Adults having certain heart procedures at Aurora St. Luke's Medical Center during a specific time period.You have a weakened immune system or regularly take high doses of steroids.You have had a procedure involving the femoral artery or vein within the past 10 days, experienced any vascular complications, or have a remaining blood clot.You have a history of bleeding problems, blood clotting issues, or a low platelet count.You have plans for a procedure involving the femoral vein or artery in the next 30 days.All access for drawing blood from an artery should be from the wrist.You had a large introducer sheath used during a vein procedure.Your femoral arteries or veins are smaller than 5 millimeters in diameter.You have medical devices implanted in your blood vessels.You have bleeding around the area where the procedure is being done.You cannot have a tube inserted into your wrist artery.You have experienced complications during a procedure that were not caused by the Perclose ProGlide SMC closure device.You have taken LMWH (Low Molecular Weight Heparin) within 8 hours before or after the procedure.You are very overweight (BMI over 40) or underweight (BMI under 20).You have an ongoing infection or inflammation near the groin area.You have other serious health problems and are not expected to live for another year.
- Group 1: Figure 8 Suture - LARGE-BORE PROCEDURES
- Group 2: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are partaking in this trial?
"Affirmative. Clinicaltrials.gov showcases that this trial is currently recruiting and was first posted on April 23rd 2021. A total of 110 people need to be enlisted from a single facility, with the study's most recent update being June 1st 2022."
Are there any vacancies in this experiment that participants can join?
"Information on clinicaltrials.gov verifies that this research is currently in search of patients. The study was first posted online on April 23rd 2021 and underwent its last amendment during the month of June, 2022."
What are the chief aims of this inquiry?
"This clinical trial will be assessed by the time it takes patients to ambulate, with secondary metrics including access site complications (e.g. hematoma and fistulae), mortality due to vascular issues, as well as total hospital stay duration from sheath removal to discharge."
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