Ventricle from Atrium Heart Failure

Medtronic, Inc0 个研究点目标入组 60 人开始时间: 2019年9月18日最近更新: 2023年2月13日

适应症

试验速览

暂无简介。

•1. Indicated for a CRT device system according to local guidelines
•2. Implanted with a market-released Medtronic CRT device and a market-released Medtronic LV lead
•3. Able to sign and date the study Informed Consent (IC) form
•4. 18 years of age or older, or of legal age to give informed consent per local law
•5. Subject is willing and able to comply with the study protocol

•1. Permanent/persistent AF or presenting with AF with ventricular rate = 90 BPM
•2. CIED or has another confounding device (e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator). Insertable cardiac monitors (ICMs) are acceptable.
•3. Requires right-sided venous access or a right-sided device implant
•4. Contraindication for standard transvenous cardiac pacing (e.g. mechanical right heart valve)
•5. History of valve repair or replacement
•6. Previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt
•7. Post heart transplant (subjects waiting for heart transplants are allowed in the study)
•8. Unstable angina pectoris or has had an acute myocardial infarction (MI) within the past 30 days
•9. Currently enrolled or planning to enroll in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
•10. Congenital heart disease
•11. Hypertrophic cardiomyopathy
•12. History of chronic dialysis therapy
•13. Less than 1-year life expectancy
•14. Pregnant
•15. Contraindicated for = 1.0 mg of dexamethasone acetate
•16. Subject meets any exclusion criteria required by local law
•17. Weighs more than 300 lbs (136 kg)
•18. Vulnerable adults

发起方

Medtronic, Inc