CALM-Diem
The CALM-DIEM_GER Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD. Eligible subjects with primary resistant hypertension who consent to study participation will be followed for three (3) years.
INCLUSION Criteria
- ≥ 18 years of age and ≤ 80 years of age
- Diagnosed with primary resistant hypertension
- Mean 24-hour systolic ABPM is ≥130mmHg following at least 30 days on a stable anti-hypertensive medication regimen (no changes in medication or dose) and no more than 28 days prior to implantation.
EXCLUSION Criteria
- Known or clinically suspected baroreflex failure or autonomic neuropathy
- Known significant aortoiliac or common femoral artery disease that will prohibit safe femoral access
- Hypertension secondary to an identifiable and treatable cause
- Chronic atrial fibrillation or recurrent atrial fibrillation with episode within the last twelve months
- bleeding complications or known uncorrectable bleeding diathesis;
- Current use of anticoagulation therapy, other than dual antiplateletmedications; Examples include vitamin K antagonists and novel oral anticoagulants including apixaban, rivaroxaban, dabigatran etexilate and edoxaban.
- Persistent symptomatic orthostatic hypotension (>20/10 mmHg);
- History of myocardial infarction or unstable angina within the past three months; History of cerebral vascular accident (stroke or TIA) within the past year
- Chronic kidney disease (eGFR calculated by the Modification of Diet in Renal Disease equation <45 ml/min);
- Prior carotid surgery, therapeutic radiation, or endovascular stent placement in either carotid region;
- Severe valvular or structural heart disease (excluding LV hypertrophy)
- Severe chronic obstructive pulmonary disease, severe pulmonary hypertension;
- Carotid duplex studies demonstrating obstructive carotid disease, plaque, ulceration or >150 micron intima-media thickness (IMT) at the site of implantation and/or proximal to the carotid artery bulb and ≥50% disease distal to the carotid artery bulb, including the intracranial circulation;
- Significant obstructive vascular disease, calcification or plaque of aortic arch and great vessels by ultrasound, CTA or MRA;
- Renal artery stenosis >50% or systolic gradient >10mmHg in borderline cases diagnosed by renal artery imaging in the last 36 months.
Ansprechpartner im Studienzentrum
Neurath,
Barbara
Leitung Studienambulanz (Geb. 24)
Dr.
Wachter,
Angelika
Stellv. Leitung Studienzentrum (Geb. 24)
