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To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
This is an open-label, multicenter, first-in-man clinical trial to be conducted inside the United States. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system.
Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MobiusHD™ | Experimental | MobiusHD™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MobiusHD™ | Device | Implant that is placed in the carotid sinus to control hypertension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of Participants with Adverse Events | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Office Blood Pressure (OBP) | Change in Systolic Office Blood Pressure (OBP) compared to baseline. | 3 years |
| Change in Systolic Ambulatory Blood Pressure (ABPM) | Change in Systolic Ambulatory Blood Pressure (ABPM) measured at 3 and 6 months compared to baseline values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark C Bates, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, P.C. | Birmingham | Alabama | 35211 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35144789 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MobiusHD™ | MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MobiusHD™ | MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | Number of Participants with Adverse Events | Posted | Number | participants | 3 years |
|
|
Adverse event data were collected through study completion (3 years).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MobiusHD™ | MobiusHD™ MobiusHD™: Implant that is placed in the carotid sinus to control hypertension. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension - acute | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain - puncture site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Affairs | Vascular Dynamics | 949-942-1640 | clinical@vasculardynamics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2014 | Dec 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 months |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Systolic Office Blood Pressure | Mean | Full Range | mmHg |
|
|
| Secondary | Change in Systolic Office Blood Pressure (OBP) | Change in Systolic Office Blood Pressure (OBP) compared to baseline. | Of the 17 subjects enrolled, 1 subject died and 1 subject withdrew from the study. The remaining 15 subjects completed all study visits through 3 years. | Posted | Mean | Standard Deviation | mmHg | 3 years |
|
|
|
| Secondary | Change in Systolic Ambulatory Blood Pressure (ABPM) | Change in Systolic Ambulatory Blood Pressure (ABPM) measured at 3 and 6 months compared to baseline values. | Of the 17 subjects enrolled in the study, 16 subjects were available for for systolic ABPM measurements at 3 and 6 months. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| 1 |
| 17 |
| 1 |
| 17 |
| 7 |
| 17 |
| Abnormal lab finding - hypokalemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Access site complication - hemorrhage - groin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Access site complications - postprocedural | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Anesthesia complications - blurred vision | Eye disorders | Non-systematic Assessment |
|
| Arrhythmia - Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Digestive system disorder - nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Digestive system disorder - vomitting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypertension - acute | Cardiac disorders | Non-systematic Assessment |
|
| Pain - head | General disorders | Non-systematic Assessment |
|
| Respiratory Abnormalities - Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
|
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| 30 days |
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| 90 days |
|
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| 180 days |
|
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| 1 year |
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| 1.5 years |
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| 2 years |
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| 2.5 years |
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| 3 years |
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