Mobilization and Outcomes After Venous Closure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MYNX CONTROLTM VENOUS Vascular Closure Device.
- Who it may be relevant to
- Registry conditions: Venous Vascular Closure, Electrophysiology Study. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
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.
Interventions
- 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 synthet
Primary outcome measures
- Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications [Time frame: From time of index procedure through end of following day (within 48 hours)]
- Rate of access-site complications [Time frame: From time of study device introduction at first access site through 14 days post-procedure]
Eligibility criteria
Inclusion criteria
- 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.).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- South Denver Cardiology — Littleton
- KC Heart and Rhythm Institute — Overland Park
- North Carolina Heart & Vascular Research, LLC — Raleigh
Identifiers
NCT: NCT07246902 · P25-8302