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Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
NA trial testing Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES in Atrial Fibrillation in 107 participants. Completed in 31 December 2023.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 107 |
| Start date | 23 April 2021 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across United States |
Wake Forest University Health Sciences
18 and older, any sex, with Atrial Fibrillation or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The elapsed time between "device" removal and first observed and confirmed venous hemostasis
| Group | Value | 95% CI |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | 7 | 2 – 10 |
| Figure 8 Suture - LARGE-BORE PROCEDURES | 11 | 10 – 15 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | 322 | 246 – 452 |
| Figure 8 Suture - LARGE-BORE PROCEDURES | 403 | 353 – 633 |
The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay.
| Group | Value | 95% CI |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | 1257 | 1081 – 1544 |
| Figure 8 Suture - LARGE-BORE PROCEDURES | 1338 | 1171 – 1435 |
Bleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death.
| Group | Value | 95% CI |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | 0 | |
| Figure 8 Suture - LARGE-BORE PROCEDURES | 0 |
Any bleeding that does not meet the criteria for major bleeding
| Group | Value | 95% CI |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | 5 | |
| Figure 8 Suture - LARGE-BORE PROCEDURES | 4 |
Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula
| Group | Value | 95% CI |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | 0 | |
| Figure 8 Suture - LARGE-BORE PROCEDURES | 2 |
Mortality due to vascular complications
| Group | Value | 95% CI |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | 0 | |
| Figure 8 Suture - LARGE-BORE PROCEDURES | 0 |
Time frame: Within 30 days of procedure date. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Perclose ProGlide Suture-M… | Figure 8 Suture - LARGE-BO… |
|---|---|---|---|
| GI bleed | Gastrointestinal disorders | — | — |
| Severe mitral valve regurgitation | Cardiac disorders | — | — |
| Stroke | Vascular disorders | — | — |
| Bleeding and Hematoma | Surgical and medical procedures | — | — |
| Acute anemia | Blood and lymphatic system disorders | — | — |
| Oozing | Injury, poisoning and procedural complications | — | — |
| Bleeding | Injury, poisoning and procedural complications | — | — |
| Reaction | System | Perclose ProGlide Suture-M… | Figure 8 Suture - LARGE-BO… |
|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | — | — |
| Oozing | Injury, poisoning and procedural complications | — | — |
| Bleeding | Injury, poisoning and procedural complications | — | — |
| Hematuria | Renal and urinary disorders | — | — |
| Bilateral groin bruising/ecchymosis | Injury, poisoning and procedural complications | — | — |
| Wrist/forearm pain/swelling and bruising | Injury, poisoning and procedural complications | — | — |
| Atypical chest pain | Cardiac disorders | — | — |
| Chest pain | Infections and infestations | — | — |
| Severe headache and hypertension | General disorders | — | — |
Most-reported serious reactions: GI bleed, Severe mitral valve regurgitation, Stroke, Bleeding and Hematoma, Acute anemia, Oozing, Bleeding.
Data from ClinicalTrials.gov NCT04632641 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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