Catheter Ablation, RadiofrequencyNCT07910227
Early Ambulation Safety Evaluation, Ultrasound-guided Percutaneous Venous Closure
A study testing VASCADE MVP and MVP XL in people with Catheter Ablation, Radiofrequency, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Ablation, Radiofrequency
- What is being tested?
- VASCADE MVP and MVP XL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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).
Who cannot join
- 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
Show all 19Show fewer
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Penn Presbyterian Medical Cente r
Philadelphia, Pennsylvania, 19104
Elizabeth Medenilla, 215-662-9084, Elizabeth.Medenilla@pennmedicine.upenn.edu
Benjamin D'Souza, MD
About this study
Official title: Early Ambulation Safety Evaluation, Ultrasound-guided Percutaneous Venous Closure. (EASE-UP)
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.
Read the detailed description
This is a single-institution, prospective, single-arm, adaptive design study to evaluate reduced Time to Ambulation (TTA) with use of the VASCADE MVP and MVP XL Commercial Devices for the management of the femoral venotomy after catheter-based interventions.
Ambulation attempts occur after physician prescribed bedrest orders are met. Typical physician bedrest orders are 2-4 hours and can vary among and within hospital practices. We hypothesis that in patients undergoing catheter-based procedures and using VASCADE MVP or MVP-XL devices for vascular closure, reduction of post-procedural bedrest duration from the typical practice of 2-4 hours to 90 minutes is feasible and/or subsequently 60 minutes and will result in a shorter time to ambulation without an unacceptable increase in major access site-related complications.
- Cohort A (n=50): Target physician orders of 90 minutes bedrest (TTA attempt at 90 minutes ± 15 min). If ≤1 patient has major access site complication(s), enrollment in Cohort B commences. If >1 patient has major access site complication(s), an additional 50 patients are enrolled in Cohort A.
- Cohort B (n=50): Target of 60 minutes bedrest (TTA attempt at 60 minutes + 15 minutes). If ≤1 patient has major access site complication(s) and 0 patients had complications in Cohort A, enrollment in Cohort C commences. If >1 major access site complication, an additional 50 patients are enrolled in Cohort A. If Cohort A had 1 patient with major access site complications, and 1 patient has major access site complication(s) in Cohort B, an additional 50 patients are enrolled in Cohort A.
- Cohort C - Confirmatory (n=50): Proceeds if Cohort B is successful. Target of 60 minutes bedrest (TTA attempt at 60 minutes + 15 minutes). Cohorts are enrolled sequentially after a brief pause evaluating safety at 30-day follow-up.
The maximum allowable patients with major complications across all cohorts is 2; If two patients have major complications, an additional 50 patients will be enrolled in Cohort A.
- Conditions
- Catheter Ablation, Radiofrequency
- Being tested
- VASCADE MVP and MVP XL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VASCADE MVP and MVP XLDevice
used for percutaneous closure of femoral venous access sites following catheter-based interventions
| Study group | Role | What they receive |
|---|---|---|
| VASCADE MVP and MVP XL | Other | FDA approved devices Receives: Device: VASCADE MVP and MVP XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Ambulation
Defined as the elapsed time between removal of the final closure device and when the subject stands and walks 20 feet without evidence of venous re-bleeding from the access site. Reduction of TTA without major access site closure-related complications attributed directly to the closure method.
Measured: From enrollment to 30 day follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Ablation, RadiofrequencyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Haemonetics Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910227
- Sponsor's protocol ID
- EASE- UP
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ambulation Safety Evaluation, Ultrasound-guided Percutaneous Venous Closure. (EASE-UP)
- ClinicalTrials.gov ID
- NCT07910227
- Acronym / sponsor ID
- EASE- UP
- Conditions
- Catheter Ablation, Radiofrequency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Haemonetics Corporation
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-institution, prospective, single-arm, adaptive design study to evaluate reduced Time to Ambulation (TTA) with use of the VASCADE MVP and MVP XL Commercial Devices for the management of the femoral venotomy after catheter-based interventions.
Ambulation attempts occur after physician prescribed bedrest orders are met. Typical physician bedrest orders are 2-4 hours and can vary among and within hospital practices. We hypothesis that in patients undergoing catheter-based procedures and using VASCADE MVP or MVP-XL devices for vascular closure, reduction of post-procedural bedrest duration from the typical practice of 2-4 hours to 90 minutes is feasible and/or subsequently 60 minutes and will result in a shorter time to ambulation without an unacceptable increase in major access site-related complications.
- Cohort A (n=50): Target physician orders of 90 minutes bedrest (TTA attempt at 90 minutes ± 15 min). If ≤1 patient has major access site complication(s), enrollment in Cohort B commences. If >1 patient has major access site complication(s), an additional 50 patients are enrolled in Cohort A.
- Cohort B (n=50): Target of 60 minutes bedrest (TTA attempt at 60 minutes + 15 minutes). If ≤1 patient has major access site complication(s) and 0 patients had complications in Cohort A, enrollment in Cohort C commences. If >1 major access site complication, an additional 50 patients are enrolled in Cohort A. If Cohort A had 1 patient with major access site complications, and 1 patient has major access site complication(s) in Cohort B, an additional 50 patients are enrolled in Cohort A.
- Cohort C - Confirmatory (n=50): Proceeds if Cohort B is successful. Target of 60 minutes bedrest (TTA attempt at 60 minutes + 15 minutes). Cohorts are enrolled sequentially after a brief pause evaluating safety at 30-day follow-up.
The maximum allowable patients with major complications across all cohorts is 2; If two patients have major complications, an additional 50 patients will be enrolled in Cohort A.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VASCADE MVP and MVP XL | Other | Device: VASCADE MVP and MVP XLFDA approved devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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).
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VASCADE MVP and MVP XLused for percutaneous closure of femoral venous access sites following catheter-based interventions | Device | VASCADE MVP and MVP XL |
Primary outcome
Time to Ambulation
Time frame: From enrollment to 30 day follow-up visit
Defined as the elapsed time between removal of the final closure device and when the subject stands and walks 20 feet without evidence of venous re-bleeding from the access site. Reduction of TTA without major access site closure-related complications attributed directly to the closure method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VASCADE MVP and MVP XL in people with Catheter Ablation, Radiofrequency, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Medenilla (215-662-9084, Elizabeth.Medenilla@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Ambulation (time frame: From enrollment to 30 day follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.