What this study is
Simplified from ClinicalTrials.govTesting a vascular closure device (VASCADE MVP or VASCADE MVP XL) to see whether people can safely walk sooner, after about 90 or 60 minutes instead of the usual 2 to 4 hours of bed rest, in adults 18 and older who have catheter-based heart procedures.
Read the original summary from ClinicalTrials.gov
The purpose of this study is to evaluate whether patients can safely walk sooner after catheter-based heart procedures when the VASCADE MVP or VASCADE MVP XL vascular closure device is used. Patients usually rest in bed for 2-4 hours before walking. The first group in this study will attempt to walk after about 90 minutes. If safety results allow, later participants may attempt to walk after about 60 minutes.
What's being tested
- VASCADE MVP and MVP XL
Intervention · DEVICE
used for percutaneous closure of femoral venous access sites following catheter-based interventions
Study details
- Official title
- Early Ambulation Safety Evaluation, Ultrasound-guided Percutaneous Venous Closure. (EASE-UP)
- Sponsor
- University of Pennsylvania
- Conditions
- Catheter Ablation, Radiofrequency
- Enrolling
- 150 people
- Starts
- 2026-12-01
- Est. completion
- 2028-06-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥18 years of age
- Capable and willing to give informed consent
- Candidate for an elective, non-emergent catheter-based procedure via the common femoral vein
- Eligible and planned same day discharge
- Able and willing to complete Patient Experience questionnaire and standard of care follow-up (2 week automated phone call and 30-Day +/- 14 days follow-up in-person or telemed visit).
You can't join if
- Currently involved in any other investigational clinical trial that may interfere with the outcomes of this study, in the opinion of the Investigator
- Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids
- Known history of bleeding diathesis, bleeding problems following medical procedures, or coagulopathy
- Known baseline hemoglobin < 10 g/dl, hematocrit < 30%, platelet count < 100,000 cells/mm3
- Severe co-existing morbidities, with a life expectancy of less than 12 months in the opinion of the Investigator
- Known history of deep vein thrombosis or pulmonary embolism in the last 12 months
- Known allergy/adverse reaction to bovine derivatives
- Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin
- Unable to ambulate at least 20 ft at baseline
- Pregnant (known or suspected) or lactating
- Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2)
- Known planned procedures or known concomitant condition(s) that may extend ambulation attempts beyond 2-4 hours, and/or hospitalization time (e.g., staged procedure, serious co-morbidity), in the opinion of the Investigator
- Femoral vessel closure in either limb with any of the following conditions:; Planned femoral access in the next 60 days to reflect the device re-access period; Any residual hematoma, significant bruising, or known associated vascular complications; Use of an intra-vascular closure device within the previous 90 days; Access within < 10 days
- Currently known implanted vascular grafts/stents at the access site that would interfere with the planned closure procedure, in the opinion of the Investigator -
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openPenn Presbyterian Medical Cente r
Philadelphia, Pennsylvania, United States
- Elizabeth Medenilla · Contact215-662-9084Elizabeth.Medenilla@pennmedicine.upenn.edu
- Benjamin D'Souza, MD · Principal investigator
Study team
Sponsor
University of Pennsylvania
Study ID EASE- UP
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.