Controlling And Lowering Blood Pressure With the MobiusHDTM Device

Hypertension Clinical Trial

— CALM-START  

Official title:

CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02804087
• Other study ID #: CRD0339
• Status: Terminated
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: July 21, 2021

Study information

• Verified date: October 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 a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 21, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 18-70 years;

• Diagnosed with resistant hypertension;

• A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).

• A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications.

Exclusion Criteria:

• Known or clinically suspected baroreflex failure or autonomic neuropathy

• Treatable cause of resistant hypertension

• Hypertension secondary to an identifiable and treatable cause other than sleep apnea

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• MobiusHD
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.

Other:
• Sham Implantation
Sham Implantation

Locations

Country	Name	City	State
Netherlands	Maastricht UMC+	Maastricht
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	HagaZiekenhuis	The Hague	AA
Netherlands	UMCU	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Dynamics, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm.	Reduction in mean systolic 24-hour ABP	From Baseline to 90 days post-randomization
Secondary	Major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm.	Adverse Events	From Baseline to 30 days post-randomization