Rheos Diastolic Heart Failure Trial

Phase 2

Withdrawn

Conditions: Diastolic heart failure
Heart failure with preserved ejection fraction.
10019280

Registration Number: NL-OMON32245

Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1 Primary Efficacy Objectives<br /><br>To describe the effects of the Rheos Baroreflex Activation Therapy System on<br /><br>the left ventricular mass index (LVMI) at six months post-randomization.<br /><br><br /><br>2. Primary Measures of Safety<br /><br>To assess the safety of Rheos Baroreflex Activation Therapy System by<br /><br>evaluating all adverse events and estimating the serious system and procedure<br /><br>related adverse event rate through six months post-implant.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To assess the difference between randomization groups in blood pressure<br /><br>changes from pre-implant between the Rheos ON and Rheos OFF arms at 3 and 6<br /><br>months post-randomization.<br /><br>2. To assess the difference between randomization groups in the increase in the<br /><br>six-minute hall walk distance at 3 and 6 months post-randomization.<br /><br>3. To assess the difference between randomization groups in changes in E/e*<br /><br>from pre-implant between the Rheos ON and Rheos OFF arms at 3 and 6 months<br /><br>post-randomization.<br /><br>4. To assess the difference between randomization groups in the improvement in<br /><br>the Minnesota Living with Heart Failure Questionnaire index score at 3 and 6<br /><br>months post-randomization.<br /><br>5. To assess the differences between randomization groups in the reduction in<br /><br>NT-pro-BNP at 3 and 6 months post-randomization.</p><br>