Back to resultsControlling And Lowering Blood Pressure With the MobiusHDTM Device (CALM-START)
Primary Purpose
Hypertension
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MobiusHD
Sham Implantation
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
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
Sites / Locations
- HagaZiekenhuis
- Maastricht UMC+
- St. Antonius Ziekenhuis
- UMCU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
MobiusHD Implantation
Sham Implantation
Arm Description
Sham
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02804087
Brief Title
Controlling And Lowering Blood Pressure With the MobiusHDTM Device
Acronym
CALM-START
Official Title
CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to the rigorous nature of the trial and enrollment interruptions caused by COVID-19, the study enrolled only 4 of the planned 110 subjects. Due to the lack of enrollment, the study was closed.
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Dynamics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MobiusHD Implantation
Arm Type
Experimental
Arm Title
Sham Implantation
Arm Type
Sham Comparator
Arm Description
Sham
Intervention Type
Device
Intervention Name(s)
MobiusHD
Intervention Description
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Intervention Type
Other
Intervention Name(s)
Sham Implantation
Intervention Description
Sham Implantation
Primary Outcome Measure Information:
Title
The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm.
Description
Reduction in mean systolic 24-hour ABP
Time Frame
From Baseline to 90 days post-randomization
Secondary Outcome Measure Information:
Title
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.
Description
Adverse Events
Time Frame
From Baseline to 30 days post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilko Spiering, MD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Van der Heyden, MD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HagaZiekenhuis
City
The Hague
State/Province
AA
ZIP/Postal Code
2545
Country
Netherlands
Facility Name
Maastricht UMC+
City
Maastricht
ZIP/Postal Code
6229
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
UMCU
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Controlling And Lowering Blood Pressure With the MobiusHDTM Device
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