NCT02678871: TAVI-LAAC

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

Terminated NA Last updated 23 February 2023

What this trial tests

NA trial testing Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations) in Aortic Valve Disorder in 15 participants. Terminated before completion.

Timeline

8 March 2017

Primary endpoint
31 October 2022

31 December 2022

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	8 March 2017
Primary completion	31 October 2022
Estimated completion	31 December 2022
Sites	6 locations across Portugal, Italy, Switzerland, Germany

Drugs / interventions tested

• Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)
• WATCHMAN

Conditions studied

• Aortic Valve Disorder — all drugs for Aortic Valve Disorder →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Aortic Valve Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.