The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with JNC-7 defined stage II hypertension that is resistant to treatment with at least three anti-hypertension agents, one of which is a…
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To demonstrate a clinically significant reduction of office cuff systolic BP
at six months post-activation. A clinically significant reduction in office
cuff systolic BP is defined as a 10 mm Hg or greater reduction, and the
proportion of subjects meeting this success criterion at the trial endpoint
will be compared across treatment groups.
2. To demonstrate a sustained response to therapy through 12 months
post-activation. Responders at six months post-activation (defined as
randomized to the ON arm and experiencing at least a 10 mmHg reduction in
systolic BP) will be analyzed at 12 months to determine if the 10 mmHg
reduction is sustained and if the response at 12 months is at least 50% of the
response observed at 6 months.
3. To demonstrate the acute safety of Rheos therapy in the treatment of
hypertension by evaluating all system and procedure related adverse events
occurring in the first 30 days post-implant.
4. To demonstrate the long-term safety of Rheos therapy in the treatment of
hypertension by evaluating all major hypertension-related adverse events and
serious device-related adverse events occurring more than 30 days post-implant
to 13 months post-implant.
5. To demonstrate the safety of Rheos therapy activation through 6 months
post-implant.
Secondary outcome
1. To compare changes between the Rheos ON and Rheos OFF arms in
antihypertensive therapeutic index (ATI) at six months post-activation.
2. To demonstrate a clinically significant reduction of 24-hour ambulatory
systolic BP at six months post-activation. A clinically significant reduction
in 24-hour ambulatory systolic BP is defined as a 7 mm Hg or greater reduction,
and the proportion of subjects meeting this success criterion at six months
post-activation will be compared across treatment groups.
3. To demonstrate a significant absolute reduction in systolic BP at six months
postactivation, as measured by office cuff.
4. To demonstrate a significant absolute reduction in 24-hour ambulatory
systolic BP at six months post-activation.
5. To further demonstrate sustained response to therapy by evaluating an
immediate (randomized to ON) vs deferred (randomized to OFF) therapy comparison
of average absolute reduction in systolic BP as measured by office cuff at 12
months post-activation.
Background summary
Subjects with hypertension are at an increased risk of developing
cardiovascular disease. Given the trend of significant morbidity and mortality
associated with hypertension, the usual treatment goals are aggressive in terms
of 'normalizing' blood pressure level. A substantial part of subjects treated
for hypertension are unable to achieve this blood pressure level.
In response to the need for more effective treatments in subjects with
resistent hypertension, an active implantable medical device based therapy, the
Rheos System, has been developed to lower blood pressure. It works by
electrical activation of the carotid sinus baroreflex, which increass efferent
nerve traffic through the carotid sinus nerve to the medullary brain centers
that regulate autonomic tone and blood pressure.
Study objective
The purpose of this clinical trial is to demonstrate the efficacy and safety of
the Rheos system in subjects with JNC-7 defined stage II hypertension that is
resistant to treatment with at least three anti-hypertension agents, one of
which is a diuretic. This trial is being conducted as the pivotal trial for
supporting the Pre-market Approval application to FDA.
Study design
The Rheos Pivotal Trial will be conducted as a randomized, double-blinded trial
with parallel groups of subjects with JNC-7 defined Stage II hypertension (>160
mmHg systolic blood pressure) and a documented resistance to medical therapy
(i.e. at least 3 or more antihypertension medications, one of which must be a
diuretic). For the first month following device implantation, therapy will be
programmed OFF. At time point 0 (1 month post-implant), subjects will be
randomized at a 2:1 ratio into device ON (Treatment Group A) and device OFF
(Treatment Group B) groups, respectively. The first primary endpoint for this
study will be assessed at 7-months post-device implantation (6-months following
activation of the device in Treatment Group A). After completing the visit at
the 6-month time point, subjects in the OFF group will have their device turned
ON. The blind will be maintained and subjects in both groups will undergo the
same follow-up schedule for the second 6-month period as they did during the
first 6 months. At the end of 12 months of follow-up, subjects in Treatment
Group A that were considered to be responders (i.e. a 10 mmHg or greater
reduction in office cuff systolic BP) at the 6 month endpoint, will be assessed
for sustained response at this time point.
Intervention
The Rheos System is implanted during an operation procedure, which takes place
in an operation room under general or local anesthesia. The carotid bifurcation
is exposed at both sides and the electrodes are wrapped around the carotid
sinus. The battery is subcutaneously placed just below the clavicle. The
electrode leads are extended through subcutaneously tunnels from the carotid
sinus incision to the battery. The mean pocedure time is 3-3.5 hours.
Study burden and risks
The total burden for each patient is 128 hours during 5 years.
The risks associated with participation are relatively small, and are similar
to related surgical procedures involving the neck. These may include
infections, bleedings, tissue damages and the occurance of TIA or stroke.
Regular measures are taken during the implant procedure to decrease the risks
of infection, bleeding and tissue damage. In case of a blood pressure reduction
due to this therapy, long-term cardiovascular risks will decrease.
10900 73rd Avenue North Suitte 116
Maple Grove, MN 55369
US
10900 73rd Avenue North Suitte 116
Maple Grove, MN 55369
US
Listed location countries
Age
Inclusion criteria
Ten minste 21 jaar en niet ouder dan 80 jaar
Office blood pressure equal or above 160/80 mmHg
Ambulatory 24-hour systolic blood pressure equal or above 135 mmHg
Normal anatomy of carotid artery bifurcations
Full doses of anti-hypertensive treatment (3 medication with 1 diuretic)
Compliant to therapy
Not pregnant or contemplating pregnancy during study period
Exclusion criteria
Known or suspected baroreflex failure or autonomic neuropathy
Body Mass Index above 45
Myocardial infarction, unstable angina, syncope or CVA within the past 3 months
Carotid atherosclerosis producing a 50% or greater reduction in diameter
Prior surgery, radiation or endobvascular stent placement in carotid sinus region
Severe chronic kidney disease, estimated GFR below 30 ml/min
Design
Recruitment
Medical products/devices used
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 | NL16587.068.07 |