Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BackBeat Medical Inc
With
Massachusetts General Hospital
MLM Medical Labs GmbH
nabios GmbH
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject is ≥ 18 years of age
Subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary.
Subject has stable regimen of 2 or more maximally tolerated anti-hypertension medications, which is anticipated to be able to be maintained without changes for 3 months.
Subject has office systolic blood pressure measurements \> 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is ≥150 mmHg
You may not be if
Subject has known secondary cause of HTN
Subject has a history of atrial fibrillation
Subject has ejection fraction \<50%
Subject has symptoms of heart failure of NYHA Class II or more
Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
Subject is on dialysis
Subject has estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2
Subject has prior neurological events (stroke or TIA) or carotid artery disease
Subject has known autonomic dysfunction
Subject has a history of clinically significant tachyarrhythmia
Subject has had previous active device-based treatment for hypertension
Subject has an existing implant, other than a pacemaker that needs replacing
Subject with average Systolic BP \>190 mmHg
Clareo Health | Safety and Performance Study of the Moderato System
