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Clinical Trials/NL-OMON32245
NL-OMON32245WithdrawnPhase 2

Rheos Diastolic Heart Failure Trial - CVRx DHF trail

Academisch Ziekenhuis Maastricht0 sites10 target enrollmentStarted: TBDLast updated:
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Withdrawn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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