NL-OMON40595
Completed
Not Applicable
Clinical Evaluation of Safety and Performance of the BackBeat Moderato System - Moderato study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- BackBeat Medical, Inc.
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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