Barostim Therapy™ in Heart Failure with Preserved Ejection Fraction (HFrEF): A Data Collection Registry with the CE-Marked Barostim neo™ System - HFrEF Registry

CVRx Incorporated0 个研究点目标入组 500 人开始时间: 2015年10月5日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•To be eligible for this registry, subjects must meet all of the following inclusion criteria:
•1. Implanted with the Barostim Neo system per the CE-Mark approved criteria for heart failure at any time in the past.
•2. On stable, maximally-tolerated, guideline-directed heart failure medications for at least 30 days prior to implant, where stable is defined as:
•No more than a 100% increase or a 50% decrease of the dosage of any one medication other than a diuretic.
•Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above.
•Unrestricted changes in diuretics are allowed as long as the subject remains on a diuretic.
•3. Signed a CVRx-approved informed consent form for the registry.

发起方

CVRx Incorporated