AMBULATE Same Day Discharge Registry

Status unconfirmed

Conditions studied: Vascular Closure

In brief

A multi-center, prospective, single-arm post market registry, designed to collect both performance and complication outcomes when same day discharge is enabled by the study device, in sealing multiple femoral venous access sites at the completion of ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.

Key facts

Study ID

NCT04203329

Run by

Cardiva Medical, Inc.

People needed

700

Starts

2020-06-30

Expected to finish

2023-12-01

Last updated by the study team

2022-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre-Operative Inclusion:
• All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
• ≥18 years of age;
• Capable and willing to give informed consent;
• Acceptable candidate for an elective, non-emergent catheter-based paroxysmal atrial fibrillation ablation procedure with or without another arrhythmia via the common femoral vein(s) using a 6 to 12 Fr inner diameter (max 15F OD) introducer sheath
• Is accompanied by a person who will be available to assist the subject for 24 hours post-procedure and/or has access to emergency services;
• Is willing/able to stay overnight at the hospital per physician discretion.
• Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.
• Acceptable candidate for emergent vascular surgery, and/or manual compression of the venous access site;
• Intra-Operative Inclusion:
• All criteria apply:
• In the Investigator's opinion, the subject is a candidate for Same Day Discharge per protocol (e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).
• Physician or designee will be on site for discharge evaluation.
• Case completed in time for subject to be reasonably recovered and discharged according to protocol.
• All femoral venous access sites are planned to be closed with the MVP
• Note:
• Initial subject eligibility will be determined based on pre-operative screening.
• Final subject enrollment will be determined at the end the procedure, prior to closure, based on general intra-op exclusion criteria, as well as additional intraoperative criteria. Enrollment is thus determined intra-operatively, at the end of the case and just prior to closure.

You may not qualify if…

• Pre-Operative Exclusion:
• Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:
• Advanced refusal of blood transfusion, if it should become necessary;
• Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin;
• Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids;
• Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count < 100,000 cells/mm3;
• Severe co-existing morbidities, with a life expectancy of less than 12 months;
• Currently involved in any clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
• Femoral arteriotomy in either limb with any of the following conditions:
• access within < 10 days
• any residual hematoma, significant bruising, or known associated vascular complications
• use of a vascular closure device within the previous 30 days;
• Femoral venotomy in either limb with any of the following conditions:
• access within < 10 days
• any residual hematoma, significant bruising, or known associated vascular complications
• use of a vascular closure device
• Any planned procedure involving femoral arterial or venous access in either limb within the next 30 days;
• Any history of deep vein thrombosis, pulmonary embolism or thrombophlebitis;
• Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
• Females who are pregnant, planning to become pregnant within 3 months of the procedure, or who are lactating;
• Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
• Unable to routinely walk at least 20 feet without assistance;
• Known allergy/adverse reaction to bovine derivatives;
• Administration of low molecular weight heparin (LMWH) within 8 hours before or after the procedure;
• Planned procedures or concomitant condition(s) that may extend ambulation attempts beyond routine ambulation and/or hospital discharge time (e.g., staged procedure, serious co-morbidity, uncontrolled obstructive sleep apnea, congestive heart failure), in the opinion of the Investigator.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• HonorHealth — Scottsdale, Arizona, United States
• Coastal Cardiology — San Luis Obispo, California, United States
• Aurora Denver Cardiology Associates, The Medical Center of Aurora — Aurora, Colorado, United States
• MedStar Washington — Washington D.C., District of Columbia, United States
• Emory St. Joseph's Hospital — Atlanta, Georgia, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Valley Hospital — Ridgewood, New Jersey, United States
• Wake Med Hospital — Raleigh, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Texas Cardiac Arrhythmia Institute — Austin, Texas, United States
• Medical City Dallas Hospital — Dallas, Texas, United States
• Medical City Fort Worth — Fort Worth, Texas, United States
• University of Utah Health — Salt Lake City, Utah, United States
• Chippenham Hospital — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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