Mobilization and Outcomes After Venous Closure (MOVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Vascular Closure; Electrophysiology Study
• Intervention / Treatment: Device: MYNX CONTROLTM VENOUS Vascular Closure Device

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Rajesh Nathan; Phone Number: 908-528-3931; Email: rajesh.nathan@cordis.com
• Study Contact Backup: Name: Jennifer Lee; Phone Number: 559-307-7753; Email: jennifer.lee02@cordis.com

Study Locations

• United States
  • Colorado
    • Littleton, Colorado, United States, 80210
      • Recruiting
      • South Denver Cardiology
      • Contact: Kathy Siegel; Email: ksiegel@southdenver.com
      • Principal Investigator: Nicolas Palmeri, MD
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Recruiting
      • KC Heart and Rhythm Institute
      • Principal Investigator: Dhanunjaya Lakkireddy, MD
      • Contact: Rachael Koeppe; Email: rachael.koeppe@hcahealthcare.com
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • North Carolina Heart & Vascular Research, LLC
      • Contact: Alexander Kasari; Email: alexander.kasari@unchealth.unc.edu
      • Principal Investigator: Joseph Bumgarner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Ambulation	Defined as elapsed time (in hours) between removal of the final MCV VCD and when subject stands and walks 20 feet without evidence of rebleeding from any femoral venous access site.	From end of index procedure until time before hospital discharge (usually within ~24 hours of procedure)
Time to Discharge	Defined as the elapsed time (in minutes) between removal of the final MCV VCD and when the subject is discharged from the hospital, as recorded on the discharge order.	From end of index procedure until time of hospital discharge (usually within ~24 hours of procedure)
Time to Hemostasis	Defined as elapsed time (in minutes) between removal of each MCV VCD and first observed and confirmed venous hemostasis (per access site analysis).	From time of index procedure until time before hospital discharge (usually within ~24 hours of procedure)
SDD sustained MCV VCD success	Defined as the proportion of subjects who did not require hospital intervention within 14 days post-procedure due to access site-related complications	From end of index procedure through 14 days post-procedure
Device success evaluated at the end of the procedure	Defined as the ability to deploy the delivery system and deliver the PEG component to achieve hemostasis at each access site	End of index procedure
Procedural Success	Defined as the attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 14 days	From end of index procedure through 14 days post-procedure
Procedural Time	Defined as time of first sheath insertion until the time of removal of final MCV VCD.	Index procedure
Recovery room time	Defined as elapsed time (in minutes) between when the subject is transferred to recovery and when the subject is discharged from the hospital, as recorded on the discharge order.	From time of transfer to recovery room post-discharge to time of discharge (usually within ~24 hours of procedure)
Analysis of Cost Effectiveness - Comprehensive summary of clinical outcomes, resource utilization, economic proxies, patients reported outcomes and CPT codes	An analysis of cost effectiveness will be performed based on a summary of key clinical outcomes, resource utilization, economic proxies, patients reported outcomes and CPT codes	From start time of index procedure through 14 days post-procedure
Incidence of urinary catheter usage	Number/rate of patients with urinary catheters used during the procedure	From start time of index procedure through end time of index procedure
Incidence of protamine usage	Incidence of protamine usage during the procedure	From start time of index procedure through end time of index procedure
Medication Usage	Rate of patients who are administered anti-platelet, anti-coagulant, anti-thrombotic, local anesthetic, protamine or pain medication	From pre-procedure though study exit/follow-up visit (14 +/- 7 days post-procedure)

Collaborators and Investigators

• Sponsor: Cordis US Corp.
• Collaborators: NAMSA

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Catheterization; Vascular closure device; MOVE; Electrophysiology Study; Venous closure; Venous access closure; Vascular access closure; Venous Vascular Closure; MYNX CONTROL VENOUS; MOVE Registry; MYNX
• Other Study ID Numbers: P25-8302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes