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

Primary Purpose

Atrial Fibrillation, Atrial Flutter, Heart Block

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Figure 8 Suture - LARGE-BORE PROCEDURES

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Large-bore (>13F) Venous Access Procedures Inclusion Criteria:

All patients 18 years and older who are undergoing any of the following: 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.

Exclusion criteria:

Large-bore (>13F) Venous Access Procedures Exclusion Criteria:

Patients in whom introducer sheaths >25F were used in the vein during the catheterization procedure.
Patients with small femoral arteries or veins (< 5 mm in diameter).
Patients with access sites in vascular grafts.
Patients with intra-procedural bleeding around access site. Patients who cannot receive radial arterial line access.
Patients who have complications during the procedure not related to the Perclose ProGlide SMC closure device
The physician determines that they must use an alternate method as the primary venous closure method other than that which the patient was randomized to
Active systemic or cutaneous infection, or inflammation in vicinity of the groin
Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
Known history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3
Severe co-existing morbidities with life expectancy less than 12 months
Femoral arteriotomy or femoral venotomy in < 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
Planned femoral venous or arterial access within next 30 days
Unable to routinely walk at least 20 ft. without assistance
LMWH within 8 hours before or after procedure
Pregnant and/or lactating women
Extreme morbid obesity (BMI > 40 kg/m2) or underweight (BMI < 20 kg/m2)

Sites / Locations

Aurora St. Luke's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Figure 8 Suture - LARGE-BORE PROCEDURES

Arm Description

Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.

Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.

Outcomes

Primary Outcome Measures

Time to achieve hemostasis

The elapsed time between "device" removal and first observed and confirmed venous hemostasis

Time to ambulate

The elapsed time between removal of the final Perclose ProGlide SMC device (treatment arm) or removal of the final sheath (control arm), and the ability of subjects to stand and ambulate 20 feet without evidence of venous re-bleeding from the femoral access sites.

Secondary Outcome Measures

Time to discharge (TTD)/length of stay (LOS)

The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay.

Post procedure major bleeding

Bleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death.

Minor bleeding

Any bleeding that does not meet the criteria for major bleeding

Access site complications

Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV fistula

Mortality

Mortality due to vascular complications

Full Information

NCT ID

NCT04632641

First Posted

November 11, 2020

Last Updated

February 1, 2023

Sponsor

Aurora Health Care

1. Study Identification

Unique Protocol Identification Number

NCT04632641

Brief Title

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

Acronym

SAFE-VEIN

Official Title

Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial: A Randomized, Prospective Study of the Safety and Efficacy of Venous Closure Device Compared to Conventional Closure Strategies in Post Venous Access Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 23, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aurora Health Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

This study will be a prospective, randomized study of patients who are undergoing one or more of the following procedures at ASLMC: Large-Bore Procedures >13 F WATCHMAN® device placement Atrial fibrillation/flutter/SVT ablation using cryoballoon or laser balloon Leadless pacemaker Pulmonary embolism thrombectomy (Inari FlowTriever system) MitraClip transcatheter mitral valve repair RANDOMIZATION: Patients will be randomized into one of two venous closure groups after a clean stick has been achieved with no complications: Large-bore (14F-25F) venous access group (1:1) Perclose ProGlide SMC Figure 8 suture

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.

Arm Title

Figure 8 Suture - LARGE-BORE PROCEDURES

Arm Type

Active Comparator

Arm Description

Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Figure 8 Suture - LARGE-BORE PROCEDURES

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to achieve hemostasis

Description

The elapsed time between "device" removal and first observed and confirmed venous hemostasis

Time Frame

Day 1

Title

Time to ambulate

Description

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Time to discharge (TTD)/length of stay (LOS)

Description

The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay.

Time Frame

up to 5 days post procedure

Title

Post procedure major bleeding

Description

Bleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death.

Time Frame

up to 30 days post procedure

Title

Minor bleeding

Description

Any bleeding that does not meet the criteria for major bleeding

Time Frame

up to 30 days post procedure

Title

Access site complications

Description

Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV fistula

Time Frame

up to 30 days post procedure

Title

Mortality

Description

Mortality due to vascular complications

Time Frame

up to 30 days post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Large-bore (>13F) Venous Access Procedures Inclusion Criteria: All patients 18 years and older who are undergoing any of the following: 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. Exclusion criteria: Large-bore (>13F) Venous Access Procedures Exclusion Criteria: Patients in whom introducer sheaths >25F were used in the vein during the catheterization procedure. Patients with small femoral arteries or veins (< 5 mm in diameter). Patients with access sites in vascular grafts. Patients with intra-procedural bleeding around access site. Patients who cannot receive radial arterial line access. Patients who have complications during the procedure not related to the Perclose ProGlide SMC closure device The physician determines that they must use an alternate method as the primary venous closure method other than that which the patient was randomized to Active systemic or cutaneous infection, or inflammation in vicinity of the groin Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids Known history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3 Severe co-existing morbidities with life expectancy less than 12 months Femoral arteriotomy or femoral venotomy in < 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days Planned femoral venous or arterial access within next 30 days Unable to routinely walk at least 20 ft. without assistance LMWH within 8 hours before or after procedure Pregnant and/or lactating women Extreme morbid obesity (BMI > 40 kg/m2) or underweight (BMI < 20 kg/m2)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad E Mortada, MD

Organizational Affiliation

Aurora Health Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aurora St. Luke's Medical Center

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

12. IPD Sharing Statement

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

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