N/A N=30 Treatment

Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01911897 ↗

Enrolled (actual)

Serious AEs

26.7%

Results posted

Nov 2023

Primary outcome: Primary: Number of Participants With Serious Adverse Events (SAEs) — 8 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: Aug 2016

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	—

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 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

View full record on ClinicalTrials.gov →

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.