Controlling and Lowering Blood Pressure With The MOBIUSHD™
CALM-FIM_US
CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study
1 other identifier
interventional
17
1 country
7
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 May 2013
Longer than P75 for not_applicable hypertension
7 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
April 9, 2013
CompletedFirst Posted
Study publicly available on registry
April 15, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2021
CompletedResults Posted
Study results publicly available
March 3, 2022
CompletedMay 6, 2023
May 1, 2023
7.2 years
April 9, 2013
December 14, 2021
May 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
Number of Participants with Adverse Events
3 years
Secondary Outcomes (2)
Change in Systolic Office Blood Pressure (OBP)
3 years
Change in Systolic Ambulatory Blood Pressure (ABPM)
6 months
Study Arms (1)
MobiusHD™
EXPERIMENTALMobiusHD™
Interventions
Eligibility Criteria
You may qualify if:
- Office cuff SBP ≥ 160 mmHg measured per protocol instructions (Appendix IV) 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. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications)
You may not qualify if:
- Known or clinically suspected baroreflex failure or autonomic neuropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Cardiology, P.C.
Birmingham, Alabama, 35211, United States
Emory University
Atlanta, Georgia, 30308, United States
Iowa Heart Center
Des Moines, Iowa, 50309, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Rochester
Rochester, New York, 14627, United States
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219, United States
Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Related 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 Cardiovasc Interv. 2022 Feb 14;15(3):321-332. doi: 10.1016/j.jcin.2021.12.015.
PMID: 35144789DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP Clinical Affairs
- Organization
- Vascular Dynamics
Study Officials
- PRINCIPAL INVESTIGATOR
Mark C Bates, MD
West Virginia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2013
First Posted
April 15, 2013
Study Start
May 1, 2013
Primary Completion
July 8, 2020
Study Completion
April 13, 2021
Last Updated
May 6, 2023
Results First Posted
March 3, 2022
Record last verified: 2023-05