In this study the safety and performance of diagnostic electrical mapping of renal nerves by means of the ConfidenHt console and catheter is assessed in patients who are hypertensive and/or potential candidates for a renal sympathetic denervation (…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of serious adverse events (system and/or procedure related
events).
Secondary outcome
Arterial blood pressure changes to renal nerve stimulation.
Background summary
Hypertension (high blood pressure) is an epidemic, affecting nearly a billion
people worldwide. The current firstline therapy for hypertension involves
change in lifestyle and various medications. However, 20-35% of the patients
does not respond to this treatment and fail to reach target blood pressure
values. Without effective treatment, the medical condition of these
uncontrolled hypertensive patients deteriorates, hence necessitating
secondline therapies, including renal sympathetic denervation (RDN) RDN is a
new potential treatment option for patients with hypertension. With an ablation
catheter some of the nerves located near the renal artery can be destroyed
leading to a reduction in the activity of the nervous system that is
responsible for the high blood pressure. However, while this therapy proved to
be very safe, a significant proportion of the patients proved not to respond in
terms of blood pressure lowering. An important reason for the failure of the
therapy is the fact that both the location and the activity of the nerves
cannot be visualized with the currently available technology. The technology
under evaluation allows mapping of the renal nerves for providing guidance that
will allow the physician to performing a targeted RDN therapy that will
potentially increase treatment efficacy.
Study objective
In this study the safety and performance of diagnostic electrical mapping of
renal nerves by means of the ConfidenHt console and catheter is assessed in
patients who are hypertensive and/or potential candidates for a renal
sympathetic denervation (RDN) procedure.
Study design
This study is designed as a multi-center, prospective, open label, single arm
safety study to evaluate the ConfidenHt system. It consists of a screening, an
intervention and a follow up period.
Intervention
Through a puncture of the groin (under local anesthesia) a catheter is advanced
towards the renal artery around which several nerves are located which play an
important role in the control of blood pressure. The physician will aim to
visualize (map) these nerves by means of the ConfidenHT system.
Study burden and risks
Only patients with an already planned diagnostic coronary angiography and/or a
renal sympathetic denervation procedure will be considered potential candidates
for the study. With both procedures there is a specific and small risk of
complications. The additional risks due to participation in this study is
therefore very small. For patients undergoing a coronary procedure an
additional risk of damage to the renal artery exists (described in ±1:200
patients) The additional risk of nerve stimulation with the ConfidenHT system,
which is the purpose of the trial, will be very small as no ablation will be
performed for the purpose of the study.
Medinat Hayehudim St. 85
Herzliya 4614002
IL
Medinat Hayehudim St. 85
Herzliya 4614002
IL
Listed location countries
Age
Inclusion criteria
- Signed written informed consent.
- Age >18 years and <75.
- Either:
o Hypertensive patients planned to undergo elective cardiac catheterization
o Potential candidates for renal sympathetic denervation
- Main renal artery with diameter * 4.0mm.
- Glomerular Filtration Rate (GFR) >45.
- A patient who is mentally competent with the ability to understand and comply with the requirements of the study.
- The patient agrees to attend all follow-up evaluations and is willing to complete required exams and tests.
Exclusion criteria
- Previous participation in another study with any investigational drug or device within the past 30 days.
- Relevant renal artery disease (% diameter stenosis>30%, aneurysm or fibromuscular dysplasia).
- Known secondary causes of hypertension.
- The patient has a life expectancy * 12 months.
- The patient has undergone prior renal denervation, renal stenting, and/or abdominal aortic stent grafts.
- The patient has chronic oxygen use other than nocturnal support for sleep apnea.
- The patient has type I diabetes mellitus.
- The patient has had a previous organ transplant or is awaiting a renal transplant.
- Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator).
- The patient has triple ipsilateral artery ostia.
- Moderate to severe valvular heart disease.
- The patient has other concomitant conditions that may adversely affect the patient or the study outcome.
- Female who is pregnant, nursing or planning to become pregnant.
- Documented contraindication or allergy to contrast medium not amenable to treatment.
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 |
|---|---|
| ClinicalTrials.gov | NCT02777216 |
| CCMO | NL58523.078.16 |