Mobilization and Outcomes After Venous Closure

NCT07246902 | Recruiting FDA Device

• 1 other identifier: P25-8302
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Venous Vascular Closure; Electrophysiology Study

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications

  Rate of patients who successfully received a study device at all access sites and had SDD without subsequent hospitalization/intervention for access-site complications either same day post-discharge or the next day

  From time of index procedure through end of following day (within 48 hours)

• Rate of access-site complications

  Rate of access-site complications, assessed per standard of care, through 14 days post-procedure, including: * Access Site-Related Hematoma \> 6 cm documented by ultrasound * Local Access Site Infection confirmed by culture and sensitivity, treated with intramuscular or oral antibiotics * Allergic Reaction * Access site-related bleeding requiring transfusion, surgical intervention, or rehospitalization * Pulmonary embolism requiring surgical or endovascular intervention and/or resulting in death, to be confirmed by CT pulmonary angiography, lung ventilation/perfusion scan (VQ scan), or autopsy * Ipsilateral deep vein thrombosis, documented by ultrasound

  From time of study device introduction at first access site through 14 days post-procedure

Other Outcomes (12)

• Time to Ambulation

  From end of index procedure until time before hospital discharge (usually within ~24 hours of procedure)

• Time to Discharge

  From end of index procedure until time of hospital discharge (usually within ~24 hours of procedure)

• Time to Hemostasis

  From time of index procedure until time before hospital discharge (usually within ~24 hours of procedure)

Study Arms (1)

MCV VCD Treatment

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.

Device: MYNX CONTROLTM VENOUS Vascular Closure Device

Interventions

MYNX CONTROLTM VENOUS Vascular Closure Device DEVICE

The MYNX CONTROLTM VENOUS (MCV) Vascular Closure Device (VCD) 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing 6F to 12F procedural sheaths, with single or multiple access sites in one or both limbs. MCV VCD is designed to achieve femoral vein hemostasis via delivery of the GRIP TECHNOLOGY™ sealant (an extravascular, water-soluble synthetic hydrogel), using a balloon catheter in conjunction with a standard procedural sheath. The sealant is made of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the venotomy and is resorbed by the body within 30 days. The MCV VCD is supplied with a 10ml locking syringe used for balloon inflation and deflation. The catheter shaft has a silicone lubricant to facilitate insertion and withdrawal into compatible sheaths.

MCV VCD Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes patients 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.

You may qualify if:

• Able and willing to provide informed consent and to complete a follow-up visit at 14 ± 7 days post-procedure.
• 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.
• Individuals who are candidates to have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.
• 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.).

You may not qualify if:

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

Sponsors & Collaborators

• Cordis US Corp.: lead
• NAMSA: collaborator

Study Sites (3)

South Denver Cardiology

Littleton, Colorado, 80210, United States

RECRUITING

KC Heart and Rhythm Institute

Overland Park, Kansas, 66211, United States

RECRUITING

North Carolina Heart & Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

RECRUITING

Central Study Contacts

Rajesh Nathan

CONTACT

908-528-3931; rajesh.nathan@cordis.com

Jennifer Lee

CONTACT

559-307-7753; jennifer.lee02@cordis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 24, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (3)