Clinical Evaluation of Safety and Performance of the BackBeat Moderato System - Moderato study

BackBeat Medical, Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•1) Subject is >= 18 years of age
•2) Subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary.
•3) Subject has stable (for prior 2 months) regimen of 2 or more maximally tolerated anti-hypertension medications (of different drug classes), which is anticipated to be able to be maintained without changes for 3 months.
•4) Subject has office systolic blood pressure measurement > 140 mmHg on two separate days within a one week period prior to enrollment, and the average of these two measurements is >=150 mmHg. All measures are to be taken prior to morning medication (e.g. 7-10AM). If the average of the two systolic blood pressure measurements is not >=150 mmHg, or one of the BP readings is less than 140 mmHg, a third measurement can be taken, with the same stability criterion applied for study eligibility.
•5) Proximity to study center which will permit compliance with study visits for at least 4 months.

•1) Subject has known secondary cause of HTN
•2) Subject has a history in the past year of persistent atrial fibrillation or clinically significant paroxysmal atrial fibrillation (clinically significant paroxysmal atrial fibrillation is defined as atrial fibrillation that in the investigators judgment would prevent the delivery of the Backbeat HTN therapy for a significant amount of the time, over 25%).
•3) Subject has ejection fraction <50%
•4) Subject has symptoms of heart failure of NYHA Class II or more
•5) Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness >=15 mm
•6) Subject is on dialysis
•7) Subject has estimated Glomerular Filtration Rate (GFR) <30 ml/min/1.73m2
•8) Subject has prior neurological events (stroke or TIA) or carotid artery disease
•9) Subject has known autonomic dysfunction
•10) Subject has a history of clinically significant tachyarrhythmia and is not on a stable medical regimen
•11) Subject has had previous active device-based treatment for hypertension
•12) Subject has an existing implant, other than a pacemaker that needs replacing
•13) Subject is pregnant or has the possibility of becoming pregnant during the conduct of the study and is not willing to use a means of contraception during the study.
•14) Subject cannot or is unwilling to provide informed consent
•15) Subject with average Systolic BP >190 mmHg
•16) Subject is currently participating in another clinical study.

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