Study 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.
Controlling And Lowering Blood Pressure With the MobiusHDTM Device
CALM-START
CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial
1 other identifier
interventional
4
1 country
4
Brief Summary
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Aug 2017
Longer than P75 for not_applicable hypertension
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedStudy Start
First participant enrolled
August 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2021
CompletedOctober 10, 2023
October 1, 2023
3.9 years
June 14, 2016
October 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
From Baseline to 30 days post-randomization
Study Arms (2)
MobiusHD Implantation
EXPERIMENTALSham Implantation
SHAM COMPARATORSham
Interventions
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
HagaZiekenhuis
The Hague, AA, 2545, Netherlands
Maastricht UMC+
Maastricht, 6229, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM, Netherlands
UMCU
Utrecht, 3508 GA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilko Spiering, MD
UMC Utrecht
- PRINCIPAL INVESTIGATOR
Jan Van der Heyden, MD
St. Antonius Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 17, 2016
Study Start
August 24, 2017
Primary Completion
June 30, 2021
Study Completion
July 21, 2021
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share