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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 in Europe. 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 |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | The number of participants with serious adverse events reported in the study will be tabulated. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Office Cuff Blood Pressure (BP) | Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months | |
| Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months | Baseline, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Van der Heyden, MD | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cologne | Cologne | 50937 | Germany | |||
| Maastricht University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35144789 | Result | 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. | |
| 28870716 |
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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 | Number of Participants With Serious Adverse Events (SAEs) | The number of participants with serious adverse events reported in the study will be tabulated. | Posted | Count of Participants | Participants | 36 months |
|
|
36 months
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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 |
|---|---|---|---|---|---|
| Hypertensive Emergency | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access site complications | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Vascular Dynamics | 9492317602 | lgreen@vasculardynamics.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Maastricht |
| AZ |
| 6202 |
| Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3430 EM | Netherlands |
| Erasmus Medical Center | Rotterdam | 3015 | Netherlands |
| HagaZiekenhuis | The Hague | 2545 CH | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3508 GA | Netherlands |
| Spiering W, Williams B, Van der Heyden J, van Kleef M, Lo R, Versmissen J, Moelker A, Kroon A, Reuter H, Ansel G, Stone GW, Bates M; CALM-FIM_EUR investigators. Endovascular baroreflex amplification for resistant hypertension: a safety and proof-of-principle clinical study. Lancet. 2017 Dec 16;390(10113):2655-2661. doi: 10.1016/S0140-6736(17)32337-1. Epub 2017 Sep 1. |
| 25982654 | Derived | Habib N, Mahmoodi BK, Bos WJ, Tromp SC, Suttorp MJ, Bates MC, Van der Heyden J. Initial experience with therapeutic geometric modification of the carotid bulb for true resistant hypertension. EuroIntervention. 2015 May;11(1):117-20. doi: 10.4244/EIJV11I1A20. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systolic Office Blood Pressure | Mean | Standard Deviation | mmHg |
|
| 24-Hour Ambulatory Blood Pressure (Systolic Blood Pressure) | Ambulatory blood pressure monitoring (ABPM) is a method to measure blood pressure on a continuous basis for 24 hours. Ambulatory blood pressure monitoring is accomplished with a special device that consists of a blood pressure cuff worn on the arm. It's attached to a small recording device that the patient wears. The ABPM device is worn for 24 hours. | Mean | Standard Deviation | mmHg |
|
|
| Secondary | Systolic Office Cuff Blood Pressure (BP) | Posted | Mean | Standard Deviation | mmHg | Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months |
|
|
|
| Secondary | Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months | Posted | Mean | Standard Deviation | mmHg | Baseline, 3 months, 6 months |
|
|
|
| 0 |
| 30 |
| 8 |
| 30 |
| 18 |
| 30 |
| Hypotension - chronic | Cardiac disorders | Systematic Assessment | Chronic = more than 30 days post procedure |
|
| Relative hypotension - acute | Cardiac disorders | Systematic Assessment | Acute = 1-7 days post procedure |
|
| Stroke with permanent symptoms | General disorders | Systematic Assessment |
|
| Transient ischemic attack | General disorders | Systematic Assessment |
|
| Access site complications | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Hypotension - acute | Cardiac disorders | Systematic Assessment | Acute = 1-7 days post procedure |
|
| Pain | General disorders | Systematic Assessment |
|
| Relative hypotension - acute | Cardiac disorders | Systematic Assessment | Acute = 1-7 days post procedure |
|
| Skin sensation disturbance | General disorders | Systematic Assessment |
|
| Transient ischemic attack | General disorders | Systematic Assessment |
|
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