Clinical Evaluation of Safety and Performance of the BackBeat Moderato System

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A. Pacemaker phase<br /><br>A.1. Primary performance endpoint<br /><br>Moderato pacing performance will be evaluated through analysis of 24 hour<br /><br>Holter monitoring recordings. Additionally, the pacemaker performance will be<br /><br>evaluated by temporarily programming the IPG to different modes (including DDD,<br /><br>VVI) with different rate and timing parameters to evaluate appropriate clinical<br /><br>pacemaker performance.<br /><br><br /><br>A.2. Primary safety endpoint<br /><br>Incidence of device- and treatment-related serious adverse events through the<br /><br>peri-procedural and 3-month follow-up period.<br /><br><br /><br>B. Hypertension phase<br /><br>B.1. Primary performance endpoint<br /><br>Moderato - HTN device performance will be evaluated through analysis of 24 hour<br /><br>Holter monitoring recordings.<br /><br><br /><br>B.2. Primary safety endpoint<br /><br>Incidence of device- and treatment-related serious adverse events through 3<br /><br>months of treatment.</p><br>

Secondary Outcome Measures