CALM-DIEM_EUR - Controlling and Lowering Blood Pressure with the MobiusHD* - Defining Efficacy Markers ;CALM-DIEM_EUR Sub-study - Studying the Effect of the MobiusHDTM on Sympathetic Activity and Baroreflex Sensitivity;CALM-DIEM_HTN-HF Sub-study - Studying the Effect of the MobiusHD® System in Hypertensive Patients with mild Chronic Heart Failure

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 39

Inclusion Criteria

1. >= 18 years of age and <= 80 years of age;
2. Diagnosed with primary resistant hypertension;
3. Mean 24-hour systolic ABPM is >=130 mmHg following at least 30 days on a
stable anti-hypertensive medication regimen (no changes in medication or dose)
and no more than 7 days prior to implantation.For the sub-study:
1. Eligible for the CALM-DIEM Study and having passed all CALM-DIEM Study
inclusion and exclusion criteria at CALM-DIEM Study ScreeningFor the HF
sub-study:
1. Eligible for the CALM-DIEM Study and having passed all CALM-DIEM Study
inclusion and exclusion criteria at CALM-DIEM Study Screening
2. Mild to moderate chronic heart failure (New York Heart Association
(NYHA) Class II or III)ndefined

Exclusion Criteria

1. An inability provide written informed consent.
2. Known or clinically suspected baroreflex failure or autonomic neuropathy.
3. Known significant aortoiliac or common femoral artery disease that will
prohibit safe femoral access.
4. Hypertension secondary to an identifiable and treatable cause other than
sleep apnea (e.g., hyperaldosteronism, renal artery stenosis, pheochromocytoma,
Cushing's disease, co-arctation of the aorta, hyperparathyroidism and
intracranial tumor).
5. Treatable cause of resistant hypertension including, but not limited to,
improper BP measurement, volume overload and pseudotolerance (excessive sodium
intake, volume retention from kidney disease, inadequate diuretic therapy),
drug-induced or other causes (non-adherence, inadequate doses, inappropriate
combinations, NSAIDs, COX-2 inhibitors, cocaine, amphetamines, or other drugs,
sympathomimetics, oral contraceptives (confirmed cause of resistant
hypertension), adrenal steroids, cyclosporine, and tacrolimus, erythropoietin ,
licorice (including some chewing tobacco), ephedra, ma haung, bitter orange);
and excessive alcohol intake.
6. Arm circumference greater than 46 cm and/or BMI >= 45.
7. Chronic atrial fibrillation or recurrent atrial fibrillation with episode
within the last twelve (12) months.
8. History of bleeding complications with dual antiplatelet therapy in the past
or has known uncorrectable bleeding diathesis.
9. Current use of anticoagulation therapy, other than dual antiplatelet
medications. Examples include vitamin K antagonists and novel oral
anticoagulants including apixaban, rivaroxaban, dabigatran etexilate and
edoxoban.
10. Peptic ulcer disease with documented active ulcer or bleeding within the
last year.
11. History of allergy to contrast media that cannot be managed medically.
12. Persistent symptomatic orthostatic hypotension (>20/10 mmHg).
13. Persistent symptomatic syncope documented to be related to hypertension
within the last six (6) months.
14. History of myocardial infarction or unstable angina within the past three
(3) months.
15. History of cerebral vascular accident (stroke or TIA) within the past year,
and NIHSS >5 or mRs >1.
16. Chronic kidney disease (GFR calculated by the Modification of Diet in Renal
Disease equation < 45 ml/min).
17. Prior carotid surgery, radiation, or endovascular stent placement in either
carotid region.
18. Severe valvular or structural heart disease (excluding LV hypertrophy).
19. Severe chronic obstructive pulmonary disease (requiring twenty-four-hour
oxygen or oral steroids), asthma, or severe pulmonary hypertension.
20. Uncontrolled diabetes mellitus with HbA1c >= 10 %.
21. Active infection within the last month requiring antibiotics.
22. Uncontrolled co-morbid medical condition, including mental health issues,
that would adversely affect participation in the trial.
23. Co-morbid condition that reduces life expectancy to less than one (1) year.
24. Planned surgery or other procedure within the next six (6) months requiring
cessation of antiplatelet medications.
25. Pregnant or lactating females. For females of child-bearing potential, a
positive pregnancy test within seven (7) days of the pre-randomization
screening or refusal to use a medically accepted method of birth control for
the duration of the trial;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy Outcome - Change in the 24-hour systolic Ambulatory Blood Pressure<br /><br>Measurements (ABPM) from Baseline to 90 days post implant.<br /><br>Safety Outcome - 30-day major adverse clinical events (MACE) including death,<br /><br>stroke, and/or myocardial infarction.<br /><br><br /><br>Substudy HF:<br /><br>Change in cardiac function/ structure from baseline to 90 days post implant.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Peri-procedural device-related serious events (i.e., dissection, rupture,<br /><br>aneurysm)<br /><br>• Incidence of serious adverse events (SAEs) and unanticipated adverse device<br /><br>effects (UADE) reported for the population from implantation through 3 years of<br /><br>follow-up.<br /><br>• Change in ABPM from baseline to 6 months and 3 years, </p><br>