NCT02678871

Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very challenging in this population of complex and frail subjects. Since the percutaneous left atrial appendage (LAA) closure with the WATCHMAN device proved promising safety and efficacy results in randomized comparisons with OAC (current standard of care), the aim of the current study is to assess the feasibility and the early safety of performing TAVI with the Lotus System and percutaneous LAA closure with the WATCHMAN device at the same session.

Conditions

• Aortic Valve Disorder

Interventions

Type	Name	Description
DEVICE	Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)	Patients meeting clinical and anatomical pre-requisites will undergo TAVI with the Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)
DEVICE	WATCHMAN	LAA closure with the WATCHMAN device

Timeline

• Start date: 2017-03-08
• Primary completion: 2022-10-31
• Completion: 2022-12-31
• First posted: 2016-02-10
• Last updated: 2023-02-23

Locations

6 sites across 4 countries: Germany, Italy, Portugal, Switzerland