๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-08-27

Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET (NCT05464511)

Impact of Steerable Delivery Sheaths on Successful Closure of Left Atrial Appendage With AMULET Dual Mechanism Closure Device (STEER-CLOSE Study)

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: Kansas City Heart Rhythm Research Foundation

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

The novel Amplatzer steerable delivery sheath (Abbott Vascular) is found to be safe and effective in performing LAAO procedure. However, the procedural outcomes have not been compared with the traditional non-steerable fixed curve sheath. In this study investigators aim to compare the outcome of patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath versus a novel steerable sheath.

Who can join: Review the eligibility criteria below.

Location: Menorah Medical Center โ€” Overland Park, Kansas

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath. (OTHER)

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 (7 Sites)

  • Menorah Medical Center โ€” Overland Park, Kansas
  • Kansas City Heart Rhythm Institute โ€” Overland Park, Kansas
  • Overland Park Regional Medical Center โ€” Overland Park, Kansas
  • Centerpoint Medical Center Clinic โ€” Independence, Missouri
  • Centerpoint Medical Center โ€” Independence, Missouri
  • Research Medical Center Clinic โ€” Kansas City, Missouri
  • Research Medical Center โ€” Kansas City, Missouri

๐Ÿ“ž Contact the Study Coordinator

Phone: (816) 651-1969

Email: datkins@kchrf.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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†—