Electrophysiology Study, Venous Vascular Closure
Conditions
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
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.
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
DEVICEMYNX 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.
Sponsors
Cordis US Corp.
NAMSA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications | From time of index procedure through end of following day (within 48 hours) | 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 |
| Rate of access-site complications | From time of study device introduction at first access site through 14 days post-procedure | 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 |
Countries
United States
Outcome results
None listed