Veritas Study

Résumé de l'étude

In this study, patients suffering from atrial fibrillation, which is not caused by a heart valve defect, participate. The study investigates how effective and safe the Amulet 2 implant medical device is. This medical device is an advancement of the approved Amulet implant. The Amulet 2 implant closes the left atrial appendage in the heart and aims to reduce the formation of blood clots and their transport from the left atrial appendage to other parts of the body, thus leading to a reduced risk of stroke. The Amulet 2 implant is not yet approved in Switzerland. After patients receive the Amulet 2 implant, data on safety and efficacy will be collected over a period of approximately 2 years, with study participants attending follow-up appointments after 45 days, 6 months, 12 months, and 24 months. About 475 patients will be included in the study, with about 60 in Switzerland. The study will be conducted at approximately 40 clinics worldwide. The total study duration will be about 3 years.

(BASEC)

Intervention étudiée

Before a study-specific examination is conducted, a signed patient information and consent form must be present. Participation in the study is completely voluntary for patients. During the preliminary examinations, it will be determined whether patients are eligible for the study. If the patient receives the Amulet 2 implant, the implantation takes about 1-2 hours. After discharge from the clinic, follow-up checks are carried out after 45 days, 6 months, 12 months, and 24 months. The appointments after 6 months and after 24 months can be conducted by phone. For all other study appointments, study participants must appear in person to the study staff. During these follow-up checks, routine as well as study-specific examinations are performed. The study-specific examinations consist of questionnaires that the patient must fill out or that the doctor must ask. Additionally, a pregnancy test is conducted for women of childbearing age. At the appointment after 12 months, a type of cardiac imaging (heart CT or transesophageal echocardiography) is performed. For patients with a stroke, an additional study-specific CT of the heart may be performed. After 2 years, the study is completed for the patients. They will then be treated according to the prevailing internal clinical guidelines.

(BASEC)

Maladie en cours d'investigation

Patients have atrial fibrillation that does not originate from the heart valve. They have an increased risk of stroke as well as systemic embolism, which makes them suitable for short-term therapy with anticoagulant medications.

(BASEC)

Sponsor

USA: Abbott Medical 177 County Road B East St. Paul, MN 55117 United States EU-Sponsor: St. Jude Medical Coordination Center BV Corporate Village, Da Vincilaan Da Vincilaan 11 1935 Zaventem Belgium Sponsor’s representative in Switzerland: Abbott Medical (Schweiz) AG Neuhofstrasse 23 CH-6341 Baar

(BASEC)

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale d'éthique de Berne

(BASEC)

Date d'approbation du comité d'éthique

07.01.2025

(BASEC)

Résultats de l'essai