๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-05

Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis (NCT07116551)

Abbott BE TAVI Early Feasibility Study: Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Abbott Medical Devices

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.

Who can join: Review the eligibility criteria below.

Location: Via Christi Regional Medical Center โ€” Wichita, Kansas

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (5 Sites)

  • Via Christi Regional Medical Center โ€” Wichita, Kansas
  • Abbott Northwestern Hospital โ€” Minneapolis, Minnesota
  • Columbia University Medical Center/New York-Presbyterian โ€” New York, New York
  • Montefiore Medical Center - Moses Division โ€” The Bronx, New York
  • Clinique Pasteur Toulouse โ€” Toulouse, Midpyre

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Symptomatic Severe Aortic Stenosis

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—