Recovery and outcomes after closing a vein access site

MOVE - Mobilization and Outcomes After VEnous Closure - A Prospective Registry of Real-World Outcomes/Usage/Evidence for the MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F

This registry will test whether the MYNX CONTROL™ VENOUS device safely seals femoral venous access sites in people having catheter-based endovascular procedures with 6F–12F sheaths.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Sex: All
• Sponsor: Cordis US Corp. (Industry-sponsored)
• Locations: 3 sites (Littleton, Colorado and 2 other locations)
• Trial ID: NCT07246902 on ClinicalTrials.gov

What this trial studies

This is a single-arm, prospective, multi-center observational registry collecting real-world outcomes after venous access site closure using the MYNX CONTROL™ VENOUS 6F–12F device. About 300 participants will be enrolled across roughly 15 sites in the United States. Eligible participants undergo catheter-based procedures with one or more venous accesses and have their access closed with the device per the instructions for use, with same-day discharge as a consideration. Investigators will record device usage practices, closure success, complications, and a follow-up visit at about 14 ± 7 days.

Who should consider this trial

Good fit: Adults having catheter-based endovascular procedures using 6F–12F sheaths who are candidates for venous closure with MYNX CONTROL™ VENOUS per the device instructions and are deemed suitable for same-day discharge.

Not a fit: Patients with local groin infection, pre-closure hematoma, palpable aneurysm or bruit, or those not eligible for same-day discharge or requiring alternative closure methods are unlikely to benefit from this device in the study context.

Why it matters

Potential benefit: If successful, this registry could confirm that the device reliably seals femoral venous access and support safer, quicker recovery and same-day discharge for appropriate patients.

How similar studies have performed: Previous post-market and registry data for vascular closure devices, primarily arterial devices, have shown acceptable hemostasis and safety, but dedicated large-scale venous closure data are limited, making this registry an expansion of real-world evidence.

Eligibility criteria

Inclusion Criteria

1. Able and willing to provide informed consent and to complete a follow-up visit at 14 ± 7 days post-procedure.
2. Individuals undergoing catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs.
3. Individuals who are candidates to have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.
4. At the time of enrollment, the Investigator deems the subject a candidate for same-day discharge (SDD) per standard of care (no procedure related events/complications e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).

Exclusion Criteria

1. Presence of bruit, palpable aneurysm, significant candida or groin infection.
2. Prior to closure, presence of hematoma in the accessed limb.
3. Currently involved in any other clinical trial that may interfere with the outcomes of this study as determined by the Investigator.
4. Planned use of other closure devices or techniques other than MYNX CONTROL™ VENOUS VCD 6F-12F.
5. Life expectancy \<12 months.

Where this trial is running

Littleton, Colorado and 2 other locations

• South Denver Cardiology — Littleton, Colorado, United States (Recruiting)
• KC Heart and Rhythm Institute — Overland Park, Kansas, United States (Recruiting)
• North Carolina Heart & Vascular Research, LLC — Raleigh, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Rajesh Nathan

Conditions Venous Vascular Closure; Electrophysiology Study; Venous closure; Venous access closure; Vascular access closure; Vascular closure device; MYNX CONTROL VENOUS; MOVE Registry