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Suture Closure Methods for Cardiac Procedures (SAFE-VEIN Trial)

N/A
Waitlist Available
Led By Mohammad E Mortada, MD
Research Sponsored by Aurora Health Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 18 years and older undergoing WATCHMAN® device placement, atrial fibrillation ablation using cryoballoon or laser balloon, leadless pacemaker, Pulmonary embolism thrombectomy (Inari FlowTriever system), MitraClip transcatheter mitral valve repair at Aurora St. Luke's Medical Center from date of IRB approval through December 2022
All arterial line access should be radial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post procedure
Awards & highlights

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.

Eligible Conditions
  • 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 below
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Adults having certain heart procedures at Aurora St. Luke's Medical Center during a specific time period.
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All access for drawing blood from an artery should be from the wrist.

SAFE-VEIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to achieve hemostasis
Time to ambulate
Secondary outcome measures
Access site complications
Minor bleeding
Mortality
+2 more

SAFE-VEIN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURESExperimental Treatment1 Intervention
Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Group II: Figure 8 Suture - LARGE-BORE PROCEDURESActive Control1 Intervention
Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.

Find a Location

Who is running the clinical trial?

Aurora Health CareLead Sponsor
41 Previous Clinical Trials
15,672 Total Patients Enrolled
Mohammad E Mortada, MDPrincipal InvestigatorAurora Health Care

Media Library

Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES Clinical Trial Eligibility Overview. Trial Name: NCT04632641 — N/A
Pulmonary Embolism Research Study Groups: Figure 8 Suture - LARGE-BORE PROCEDURES, Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
Pulmonary Embolism Clinical Trial 2023: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES Highlights & Side Effects. Trial Name: NCT04632641 — N/A
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES 2023 Treatment Timeline for Medical Study. Trial Name: NCT04632641 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~28 spots leftby Mar 2025