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

NCT02678871 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-02-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Lorenz Räber, Prof. Dr. · Inselspital Bern, Universitätsklinik für Kardiolgie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • Germany
  • Italy
  • Portugal
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678871 on ClinicalTrials.gov