N/A N=17 Treatment

Controlling and Lowering Blood Pressure With The MOBIUSHD™

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01831895 ↗

Enrolled (actual)

Serious AEs

5.9%

Results posted

Mar 2022

Primary outcome: Primary: Adverse Events — 1; 1; 1; 1 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MobiusHD™ (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vascular Dynamics, Inc.
Primary completion: Jul 2020

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	—

Summary

To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

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

View full record on ClinicalTrials.gov →

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.