NL-OMON46157
Withdrawn
Not Applicable
Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients with Hypertension: A Double-Blind Randomized Trial - Moderato System: A Double-Blind Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- high blood pressure
- Sponsor
- BackBeat Medical, Inc.
- Enrollment
- 10
- Status
- Withdrawn
- 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 requires the implant or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker
- •3\) Subject has stable (for prior 6 weeks) hypertension treatment with at least 1 antihypertensive drug, which is anticipated to be able to be maintained without changes .Stable is defined as being on the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks
- •4\) Subject has an average 24 hour ambulatory systolic blood pressure of \* 130mmHg (with directly observed medical therapy, DOT) and unattended automatic average and office systolic blood pressure \*140 mmHg
- •5\) Subject is able to comply with study visits for at least 13 months (e.g., is capable
- •and is willing to travel to/from the center for all scheduled study visits)..
Exclusion Criteria
- •1\) Subject has a known secondary cause of HTN
- •2\) Subject with average ambulatory or office systolic BP \>195 mmHg
- •3\) Subject has permanent atrial fibrillation
- •4\) Subject has a history of significant paroxysmal atrial fibrillation/flutter burden (defined as \>25% of beats). Fibrillation/flutter burden will be determined by pacemaker interrogation (for those already having a pre\-existing pacemaker) or, otherwise, by patient history.
- •5\) Subject has ejection fraction \<50%
- •6\) Subject has symptoms of heart failure, NYHA Class II or greater
- •7\) Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness \*15 mm
- •8\) Subject is on dialysis
- •9\) Subject has estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1\.73m2
- •10\) Subject has prior neurological events (stroke or TIA) within the past year or an event at any prior time that has resulted in residual neurologic deficit
Outcomes
Primary Outcomes
Not specified
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