Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Overview

Información sobre este estudio

The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Subjects ≥ 18 years of age.
- Documentation of any of the following clinical criteria:

- CHA2DS2-VASc ≥ 4 with age ≥ 65;
- CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP;
- CHA2DS2-VASc = 3 with age ≥ 75
- CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
- CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or
elevated NT-proBNP.

Exclusion Criteria:

- Clinically significant atrial fibrillation or atrial flutter:

- Anytime in the past; and
- Documented by an electrocardiographic recording; and
- Episode lasting 6 minutes or longer1*.

- Prior procedure involving opening the pericardium or entering the pericardial space.
- Prior LAA occlusion, exclusion, or removal (surgical or percutaneous).
- Planned cardiac surgical procedure using non-sternotomy approaches.
o Partial sternotomies will be allowed.
- Patients whose planned procedure is a heart transplant or implantation of any
ventricular assist devices.
- Active endocarditis.
- Active systemic infection at the time of cardiac surgery requiring antibiotics,
including known SARS-CoV2 infections regardless of symptoms.
- Known allergy to Nitinol or nickel sensitivity.
- Known medical condition with expected survival of less than 1 year.
- Other comorbidities that in the investigator's opinion make the subject unsuitable
candidate to complete the protocol required visits.
- Current enrollment in an investigation or trial or an investigational devices or
investigational drug that would interfere with this trial.
- Mental impairment or other psychiatric conditions which may not allow the patient to
understand the nature, significance, and scope of the trial.
- Pregnancy.
- Known severe symptomatic carotid disease.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Gabor Bagameri, M.D.

Abierto para la inscripción

Contact information:

Lukman Tata M.S.

(507) 255-4158

Tata.Lukman@mayo.edu

More information

Publicaciones

Publications are currently not available