Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02827032
NCT02827032
Recruiting
Not Applicable

Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers

Vascular Dynamics, Inc.22 sites in 3 countries200 target enrollmentJuly 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Vascular Dynamics, Inc.
Enrollment
200
Locations
22
Primary Endpoint
Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.

Detailed Description

The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
June 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation.

Exclusion Criteria

  • •Known or clinically suspected baroreflex failure or autonomic neuropathy
  • •Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair Medisch Centrum Utrecht)
  • •Inclusion Criteria:
  • •Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening
  • •Exclusion Criteria:
  • •Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be discontinued safely
  • •Underlying conditions that prohibit microneurography, performance of a Valsalva maneuver and/or magnetic resonance imaging

Outcomes

Primary Outcomes

Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)

Time Frame: Baseline to ninety (90) days post treatment

Change in the mean 24-hours systolic Ambulatory Blood Pressure

Secondary Outcomes

  • Incidence of Adverse Events(Baseline to three (3) years post treatment)

Study Sites (22)

Loading locations...

Similar Trials

Active, not recruiting
Not Applicable
CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™HypertensionResistant Hypertension
NCT03179800Vascular Dynamics, Inc.300
Terminated
Not Applicable
Controlling And Lowering Blood Pressure With the MobiusHDTM DeviceHypertension
NCT02804087Vascular Dynamics, Inc.4
Completed
Not Applicable
Controlling and Lowering Blood Pressure With The MOBIUSHD™Hypertension
NCT01831895Vascular Dynamics, Inc.17
Completed
Not Applicable
Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)Hypertension
NCT01911897Vascular Dynamics, Inc.30
Completed
Phase 3
BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstemHypertension
NCT01482364Hemo Sapiens, Inc.183