Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
Completed · NCT05936996
Conditions: Femoral Arteriotomy Closure
At a glance
- Research payments reported, 2025
- $419,659
- U.S. investigators named
- 9
- Sites paid
- 9
- Planned or actual enrollment
- 258
About the trial
- Sponsor
- Essential Medical, Inc. (with Vascular Solutions LLC, Teleflex Medical Inc)
- Tested
- MANTA Vascular Closure Device (device)
- Dates
- Started 2023-11-15; completion 2025-10-30
- Results posted
- Yes
This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.
From ClinicalTrials.gov, last updated 2026-10-23. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Arrow International, Inc. reported $419,659 in research payments for this study in 2025 (63 payments).
Products named: Manta
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Vijaykumar S. Kasi, MD, PHD Interventional Cardiology · Orlando, FL
- Siddharth A. Wayangankar, MD Interventional Cardiology · Jacksonville, FL
- Pedro A. Villablanca Spinetto, M.D. Cardiology · Detroit, MI
- Manaf Assafin, MD Interventional Cardiology · Bronx, NY
- Vijay S. Iyer, MD, PHD Cardiology · Amherst, NY
- Sahil Khera, M.D., M.P.H. Interventional Cardiology · New York, NY
- Bruce Rutkin, MD Cardiology · Manhasset, NY
- Kashish Goel, MBBS Interventional Cardiology · Nashville, TN
- Angel E. Caldera, M.D. Interventional Cardiology · Round Rock, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Baylor Scott & White $73,334
- Icahn School of Medicine at Mt Sinai $72,271
- Henry Ford Health Hospital, MI $58,798
- Montefiore Medical Center, NY $55,095
- Vanderbilt University Medical Center, TN $50,779
- Orlando Health, FL $49,307
- Northwell Health $44,188
- University at Buffalo $14,988
- Baptist Health Research Institute $900
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.