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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: MobiusHD

• Registration Number: NCT01911897
• Lead Sponsor: Vascular Dynamics, Inc.

Brief 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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-30
• Primary Completion: 2016-08
• Disposition First Submitted: 2018-02-20
• Disposition First Submitted QC: 2018-02-22
• Disposition First Posted: 2018-02-26
• Study Completion: 2020-02-28
• Results First Submitted: 2023-10-04
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Results First Posted: 2023-11-22
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MobiusHD	MobiusHD	MobiusHD

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events (SAEs)	36 months	The number of participants with serious adverse events reported in the study will be tabulated.

Secondary Outcome Measures

Name	Time	Method
Systolic Office Cuff Blood Pressure (BP)	Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months
Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months	Baseline, 3 months, 6 months

Trial Locations

Locations (6)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

University of Cologne; 🇩🇪 Cologne, Germany

Maastricht University Medical Center; 🇳🇱 Maastricht, AZ, Netherlands

HagaZiekenhuis; 🇳🇱 The Hague, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands