The purpose of this clinical investigation is to verify the efficacy and safety of the CVRx Neo Baroreflex Activation Therapy System in subjects who qualify for the implantation for a Baroreflex Activation Therapy System.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To describe the reductions in office cuff systolic blood pressure through six
months of Baroreflex Activation Therapy® with the Neo system, relative to the
screening blood pressure measurements.
To describe the safety of Baroreflex Activation Therapy utilizing the Neo
system in the treatment of hypertension by evaluating all adverse events and
estimating the rate of all system and procedure related complications through
the 6-month visit.
Secondary outcome
NVT
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.
In this trial a new model, the Neo System will be investigated on safety and
efficacy. When it's safe and effective, patients will have many benefits: the
device is much smaller, has a longer longevity and only one lead will be
implanted, what shortens the time of operation.
Study objective
The purpose of this clinical investigation is to verify the efficacy and safety
of the CVRx Neo Baroreflex Activation Therapy System in subjects who qualify
for the implantation for a Baroreflex Activation Therapy System.
Study design
The Neo Non-Randomized Hypertension Study will be conducted as a
non-randomized, open-label, verification study in patients diagnosed with drug
resistant hypertension. Up to sixty subjects will be implanted at up to 15
clinical sites in Europe and Canada. Up to 100 subjects will be enrolled to
account for screen failures. After the patient has been determined to meet the
enrolment criteria, he/she will be implanted with the Neo System. Therapy will
be programmed OFF for the first two weeks following the implant. Two weeks
following device implantation, therapy will be turned ON. Study visits will
occur at 1, 2, 3, 5, and 6 months post-activation, quarterly through 12 months,
and semi-annually thereafter.
Intervention
The Neo System is implanted during an operation procedure, which takes place in
an operating room under general or local anesthesia. The electrode is wrapped
around the carotic sinus at one side of the neck. The battery is subcutaneously
placed below the clavicle. The electrode lead is extended through
subcutaneously tunnels from the carotic sinus incision to the battery. The mean
produre time is 1 - 2 hours.
Study burden and risks
The total burden for each patient is 52 hours during 4 years. The risks
associated with participation are relatively small, an are similar to related
surgical procedures involving the neck. These may include infections,
bleedings, tissue damages and the occurrence 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 Suite 116
Maple Grove, MN 55369
US
10900 73rd Avenue North Suite 116
Maple Grove, MN 55369
US
Listed location countries
Age
Inclusion criteria
Age at least 21 years and no more than 80 years.
Office cuff systolic blood pressure (SBP) >= 140 mmHg
Normal anatomy of carotic artery bifurcations
An optimal stable anti-hypertensive therapy
not pregnant and contemplating pregnancy during study period
compliant on therapy
Exclusion criteria
known of suspected baroreflex failure or autonomic neuropathy
Body Mass Index above 45
Myocardial Infarction, unstable angina, syncope or CVA within the past 3 months
Carotic atherosclerosis producing a 50% or greater reduction in diameter
Prior surgery, radiation, or endovascular stent placement in the carotid sinus
region
Hypertension secondary to an identifiable and treatable cause other than
sleep apnoea.
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 | NL34630.068.10 |