Condition hypertension
Treatment mobiushd™
Phase phase 1
Sponsor Vascular Dynamics, Inc.
Start date May 2013
End date December 2017
Trial size 20 participants
Trial identifier NCT01831895, CALM-FIM_US, CRD0152, G130013


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

Recruiting in the following locations…

United States Alabama, Georgia, Iowa, Louisiana, Michigan, New York, Ohio, and Tennessee
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Implant that is placed in the carotid sinus to control hypertension.

Primary Outcomes

time frame: 6 month

Secondary Outcomes

time frame: 6 Months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study
Principal investigator Mark C Bates, MD
Description This is an open-label, multicenter, first-in-man clinical trial to be conducted inside the United States. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system. Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Vascular Dynamics, Inc..