Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKansas City Heart Rhythm Research Foundation
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
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
Trial design
Treatments tested in this trial
- Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kansas City Heart Rhythm Research Foundation
Lead sponsor
Kansas City Heart Rhythm Institute
Collaborator
Source ClinicalTrials.gov