The purpose of this clinical investigation is to describe the safety and efficacy of the Rheos Baroreflex Activation Therapy System in subjects with diastolic heart failure.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1 Primary Efficacy Objectives
To describe the effects of the Rheos Baroreflex Activation Therapy System on
the left ventricular mass index (LVMI) at six months post-randomization.
2. Primary Measures of Safety
To assess the safety of Rheos Baroreflex Activation Therapy System by
evaluating all adverse events and estimating the serious system and procedure
related adverse event rate through six months post-implant.
Secondary outcome
1. To assess the difference between randomization groups in blood pressure
changes from pre-implant between the Rheos ON and Rheos OFF arms at 3 and 6
months post-randomization.
2. To assess the difference between randomization groups in the increase in the
six-minute hall walk distance at 3 and 6 months post-randomization.
3. To assess the difference between randomization groups in changes in E/e*
from pre-implant between the Rheos ON and Rheos OFF arms at 3 and 6 months
post-randomization.
4. To assess the difference between randomization groups in the improvement in
the Minnesota Living with Heart Failure Questionnaire index score at 3 and 6
months post-randomization.
5. To assess the differences between randomization groups in the reduction in
NT-pro-BNP at 3 and 6 months post-randomization.
Background summary
Heart failure has become an increasingly important public health issue,
reaching epidemic proportions. With an increasing incidence and prevalence, and
an aging population, it is expected that the heart failure epidemic will only
worsen. Heart failure can be divided into two clinical subsets based primarily
on left ventricular ejection fraction (LVEF). Systolic heart failure patients
present with large dilated hearts and low ejection fractions (EF) of < 45% and
heart failure symptoms and LVEF * 45% termed diastolic heart failure (DHF).
Approximately half of all heart failure patient are diastolic heart failure
patients. Desite recent advances in stadard heart failure treatment its
prognosis remains poor with 5-year survival rates of 43%. And following heart
failure hospitalization up to 20% mortality at one year. A novel treatment
option for these patients is the "Rheos baroreflex activation therapy" system.
Which increases afferent signals to these medullary centers causing a reduction
in sympathetic tone. Lowered sympathetic tone results in lower heart rate,
diuresis, and vasodilatation all of which function to reduce blood pressure and
potentially alleviate heart failure symptoms.
Study objective
The purpose of this clinical investigation is to describe the safety and
efficacy of the Rheos Baroreflex Activation Therapy System in subjects with
diastolic heart failure.
Study design
a prospective, randomized trial.
Intervention
implant Rheos : ON and OFF arms
Study burden and risks
The potential risks associated with this study are the known risks of surgery,
anesthesia, and baroreflex stimulation. Although the risk involved with
anesthesia and surgery is increased in the heart failure population, the
sponsor and the investigators have determined that this study is justified
because of the potential benefit of the CardioFit* treatment on patient's heart
failure symptoms and prognosis.
P. Debyelaan 25
6229 HX
Nederland
P. Debyelaan 25
6229 HX
Nederland
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22862.068.08 |