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Completed

NCT Number: NCT01911897

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cologne, Cologne, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MobiusHD

Device

Implant that is placed in the carotid sinus to control hypertension.

Primary outcomes

  1. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: 36 months

    The number of participants with serious adverse events reported in the study will be tabulated.

Secondary outcomes

  1. Systolic Office Cuff Blood Pressure (BP)

    Time frame: Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months

  2. Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months

    Time frame: Baseline, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

Vascular Dynamics, Inc.

Industry

Registry information

Official study title

CALM-FIM_EUR - Controlling and Lowering Blood Pressure With the MobiusHD - A Prospective Multicenter Safety Study

Acronym: CALM-FIM_EUR

Important dates

Study start
2013
Primary completion
2016
Study completion
2020
First posted
Jul 30, 2013
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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