Trials / Completed
CompletedNCT01911897
Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)
CALM-FIM_EUR - Controlling and Lowering Blood Pressure With the MobiusHD - A Prospective Multicenter Safety Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Vascular Dynamics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Detailed description
This is an open-label, multicenter, first-in-man clinical trial to be conducted in Europe. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MobiusHD | Implant that is placed in the carotid sinus to control hypertension. |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2016-08-01
- Completion
- 2020-02-28
- First posted
- 2013-07-30
- Last updated
- 2023-11-22
- Results posted
- 2023-11-22
Locations
6 sites across 2 countries: Germany, Netherlands
Source: ClinicalTrials.gov record NCT01911897. Inclusion in this directory is not an endorsement.