Mobilization and Outcomes After Venous Closure (MOVE)

Cordis US Corp.

Status: Enrolling

Conditions: Venous Vascular Closure; Electrophysiology Study

Treatments: Device: MYNX CONTROLTM VENOUS Vascular Closure Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07246902

P25-8302

Details and patient eligibility

About

The primary objective of this post-market registry is to collect real-world outcomes and evaluate usage practice of MYNX CONTROL™ VENOUS (MCV) Vascular Closure Device (VCD) 6F-12F in sealing femoral venous access sites in patients who have undergone endovascular procedures in a real-world setting.

Full description

The study is a single-arm, prospective, multi-center, observational, real-world registry of venous access site closures utilizing MYNX CONTROL™ VENOUS VCD 6F-12F following endovascular procedures. The study will enroll approximately 300 subjects in approximately 15 study sites in the United States.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

300 participants in 1 patient group

MCV VCD Treatment

Description:

Subjects who undergo catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs, and have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.

Treatment:

Device: MYNX CONTROLTM VENOUS Vascular Closure Device