N/A N=106 Randomized Treatment

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

Atrial Fibrillation · Atrial Flutter · Heart Block · Pulmonary Embolism and Thrombosis · Mitral Valve Repair

Bottom Line

View on ClinicalTrials.gov: NCT04632641 ↗

Enrolled (actual)

106

Serious AEs

10.0%

Results posted

May 2024

Primary outcome: Primary: Time to Achieve Hemostasis — 7; 11 Minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES (Device); Figure 8 Suture - LARGE-BORE PROCEDURES (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Achieve Hemostasis	7; 11	—
PRIMARY Time to Ambulate	322; 403	—
SECONDARY Time to Discharge (TTD)/Length of Stay (LOS)	1257; 1338	—
SECONDARY Post Procedure Major Bleeding	0; 0	—
SECONDARY Minor Bleeding	5; 4	—
SECONDARY Access Site Complications	0; 2	—
SECONDARY Mortality	0; 0	—

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.

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 (Institutional Review Board) 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 ( 40 kg/m2) or underweight (BMI < 20 kg/m2)

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Data sourced from ClinicalTrials.gov (NCT04632641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.