Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.
The MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. This study is being conducted to demonstrate the safety of U/S guided closure with MANTA VCD following TAVR procedures utilizing large bore sheaths.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Washington Hospital Center
Washington D.C., District of Columbia, United States
Henry Ford
Detroit, Michigan, United States
University of Buffalo
Buffalo, New York, United States
Baylor Scott & White
Round Rock, Texas, United States
Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication
adapted from VARC-2 Criteria
Time frame: within 30 days
Time to Hemostasis
The elapsed time between VCD deployment and first observed and confirmed arterial hemostasis.
Time frame: During the procedure
Number of Patients With Technical Success
Percutaneous vascular closure is obtained without the use of unplanned endovascular or surgical intervention.
Time frame: within 30 days
Number of Subjects With Ambulation Success
If a previously ambulatory patient (until day of TAVI) is able to ambulate for at least 20 feet/6 meters without re-bleeding.
Time frame: During procedure admission
Time to Ambulation
The elapsed time between VCD deployment and when ambulation is achieved.
Time frame: During procedure admission
Treatment Success
Time to Hemostasis ≤10 minutes and no VACR-2 Major complications
Time frame: within 30 days
Procedure Time
Elapsed time from initial skin break to time when the post-deployment angiogram is completed.
Time frame: During the procedure
Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication
adapted from VARC-2 Criteria
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sentara Northern Virginia Medical Center
Woodbridge, Virginia, United States
Vancouver General Health
Vancouver, British Columbia, Canada
Time frame: within 30 days