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

Hypertension Clinical Trial

— CALM-FIM_EUR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911897
• Other study ID #: CRD0120, CRD0233
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: February 28, 2020

Study information

• Verified date: November 2023
• Source: Vascular Dynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2020
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• MobiusHD
Implant that is placed in the carotid sinus to control hypertension.

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne
Netherlands	Maastricht University Medical Center	Maastricht	AZ
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	HagaZiekenhuis	The Hague
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Dynamics, Inc.

Countries where clinical trial is conducted

Germany,  Netherlands, 

References & Publications (1)

van Kleef MEAM, Devireddy CM, van der Heyden J, Bates MC, Bakris GL, Stone GW, Williams B, Spiering W; CALM-FIM Investigators. Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study. JACC Car — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serious Adverse Events (SAEs)	The number of participants with serious adverse events reported in the study will be tabulated.	36 months
Secondary	Systolic Office Cuff Blood Pressure (BP)		Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months
Secondary	Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months		Baseline, 3 months, 6 months