Controlling and Lowering Blood Pressure With The MOBIUSHD™ (CALM-FIM_US)

Vascular Dynamics

Status: Completed

Conditions: Hypertension

Treatments: Device: MobiusHD™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01831895

CALM-FIM_US, CRD0152, G130013

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

MobiusHD™

Experimental group

Description:

MobiusHD™

Treatment:

Device: MobiusHD™