N/A
Completed N=17
Controlling and Lowering Blood Pressure With The MOBIUSHD™
Source: ClinicalTrials.gov NCT01831895 ↗Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Mar 2022
Primary outcomePrimary: Adverse Events — 1; 1; 1; 1 participants
Summary
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Change in Systolic Office Blood Pressure (OBP) |
-26.6; -19; -18.8; -23.3; -27.5; -20.8 | — |
| SECONDARY Change in Systolic Ambulatory Blood Pressure (ABPM) |
-11.94; -16.00 | — |
Eligibility Criteria
Inclusion Criteria
- Office cuff SBP ≥ 160 mmHg measured per protocol instructions (Appendix IV) following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications)
Exclusion Criteria
- Known or clinically suspected baroreflex failure or autonomic neuropathy
Data sourced from ClinicalTrials.gov (NCT01831895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.