N/A
Completed N=30
Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)
Source: ClinicalTrials.gov NCT01911897 ↗Enrolled (actual)
30
Serious AEs
26.7%
Results posted
Nov 2023
Primary outcomePrimary: Number of Participants With Serious Adverse Events (SAEs) — 8 Participants
Summary
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
8 | — |
| SECONDARY Systolic Office Cuff Blood Pressure (BP) |
184; 147; 157; 162; 160; 160 | — |
| SECONDARY Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months |
167; 150; 145 | — |
Eligibility Criteria
Inclusion Criteria
- Office cuff SBP ≥ 160 mmHg measured per protocol instructions 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 unless patient has history of intolerance, ineffectiveness or contraindications.
Exclusion Criteria
- Known or clinically suspected baroreflex failure or autonomic neuropathy
Data sourced from ClinicalTrials.gov (NCT01911897). 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.