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Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial

NCT04632641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-10-03

Study results available
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Summary

Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures.

Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.

Conditions

  • Atrial Fibrillation
  • Atrial Flutter
  • Heart Block
  • Pulmonary Embolism and Thrombosis
  • Mitral Valve Repair
  • Sinus Node Dysfunction
  • Bradycardia
  • Brady-tachy Syndrome

Interventions

DEVICE

Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES

The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.

OTHER

Figure 8 Suture - LARGE-BORE PROCEDURES

A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Mohammad E Mortada, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632641 on ClinicalTrials.gov