NCT05464511Not yet recruiting
Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET
Impact of Steerable Delivery Sheaths on Successful Closure of Left Atrial Appendage With AMULET Dual Mechanism Closure Device (STEER-CLOSE Study)
Source: ClinicalTrials.gov · Last updated 28 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 12 Jul 2022
- Start date
- Jan 2026
- Primary completion date
- Oct 2026
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT05464511
What you commit to
- Study type: Interventional
- Planned participants: 300
- From Jan 2026 to the primary completion date, Oct 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient been/being implanted with device other than Amplatzer™ Amulet™ Left Atrial Appendage Occluder
- Pregnant or breastfeeding patients
- Prisoners
- Patients not willing to participate in the study
Who the study is looking for
- Patients with atrial fibrillation who meets the indication/criteria for left atrial appendage occlusion and undergoing implantation of Amplatzer™ Amulet™ Left Atrial Appendage Occluder device
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centerpoint Medical Center Clinic Coordinator of this site? Confirm its status | Independence | United States | Unknown status |
| Centerpoint Medical Center Coordinator of this site? Confirm its status | Independence | United States | Unknown status |
| Research Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Research Medical Center Clinic Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Kansas City Heart Rhythm Institute Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Menorah Medical Center Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Overland Park Regional Medical Center Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.