NL-OMON32245WithdrawnPhase 2
Rheos Diastolic Heart Failure Trial - CVRx DHF trail
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. Be at least 21 years of age.
- •2. Have bilateral carotid bifurcations that are below the level of the mandible.
- •3. Have a left ventricular ejection fraction * 45% within 30 days of enrollment.
- •4. Within 24 months prior to enrollment, hospital admission for heart failure or at least 2 of the signs/symptoms of heart failure that resolved on heart failure treatment.
- •5. NYHA Class II-III classification within 30 days prior to enrollment
- •6. Have an office cuff systolic blood pressure greater than or equal to 140 mmHg within 30 days prior to enrollment.
Exclusion Criteria
- •1. Have known or suspected baroreflex failure or autonomic neuropathy.
- •2. Have an arm circumference greater than 46 cm and/or a body mass index of greater than 45.
- •3. Have significant uncontrolled symptomatic bradyarrhythmias with a heart rate < 60 bpm.
- •4. Significant orthostatic hypotension.
- •5. Had a myocardial infarction or cerebral vascular accident within 3 months prior to enrollment.
Investigators
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