Aim of the study is to study a new therapeutic option for the treatment of hypertension
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: Efficacy Endpoint
1. Reduction of systolic and diastolic blood pressure at six (6) months as
measured by office-based blood pressure assessment (seated) following
therapeutic renal denervation compared to baseline according to a standardized
procedure using a validated electronic device (Omron model HEM-705 CP which
includes a printer attachment).
2. Reduction of systolic and diastolic blood pressure at six (6) months as
measured by 24-hour ambulatory blood pressure monitoring following therapeutic
renal denervation compared to baseline using a validated ABPM device.
Secondary outcome
Secondary endpoints: Safety
Acute safety of the renal denervation procedure assessed by:
1. Renal artery dissection or perforation during the procedure that requires
stenting or surgery;
2. Renal artery infarction or embolus;
3. Cerebrovascular Accident (CVA) at time of procedure;
4. Myocardial infarction at time of procedure;
5. Sudden cardiac death at time of procedure.
Long-term outcomes to further assess device safety and renal function:
6. Renal stenosis requiring an intervention documented by angiography;
7. Absence of flow limiting stenosis in the renal artery at six (6) months
follow up time points
8. Chronic symptomatic orthostatic hypotension;
9. Hypertensive emergency necessitating hospital admission, unrelated to
medication and/or non-compliance during the follow up period (2 years);
10. Reduction in estimated glomerular filtration rate > 25% during the follow
up period (2 years);
Background summary
Hypertension and its related conditions, heart failure and chronic kidney
disease, represent a significant and growing global health issue. The World
Health Organization (WHO) reports that high blood pressure afflicts one billion
people worldwide (1 in 3 adults in the developed world). The prevalence of high
blood pressure increases with age, obesity and sedentary lifestyles. Since all
three factors are on the rise worldwide, hypertension treatment represents a
large and growing clinical concern. Normal blood pressure is presently defined
as 115/75 mm Hg (measured in millimeters of mercury) where the first figure
represents systolic BP (SBP) and the second diastolic (DBP). For patients
receiving treatment for hypertension, the target of treatment is reducing blood
pressure below 140/90mm Hg. Hyper-activation of the sympathetic nervous system,
especially the renal sympathetic nerves, is a major contributor to the
pathophysiology of hypertension.
Study objective
Aim of the study is to study a new therapeutic option for the treatment of
hypertension
Study design
a non-randomized, international, multi-center, prospective, single cohort, post
market clinical follow up study.
Intervention
Patients will be treated by renal sympathetic nerve denervation using RF energy
applied with a balloon catheter. The treatment takes 30-60 seconds (depending
on the length of the renal artery) and will be applied in both renal arteries
Study burden and risks
With any interventional procedure, there are possible risks and complications.
It is believed that the risks associated with the use of the V2 Catheter are
similar to other angioplasty devices.
26052 Merit Circle Suite 106
Laguna Hills CA 92653
US
26052 Merit Circle Suite 106
Laguna Hills CA 92653
US
Listed location countries
Age
Inclusion criteria
1. Subjects who have provided written informed consent;
2. Subjects who are * 18 years and * 75 years of age;
3. Subjects who have SBP & DBP * 160/90 mm Hg based on an average of three (3) office-based blood pressure readings (seated) measured according to protocol;
4. Subjects on a stable medication regimen with * 3 anti-hypertensive drugs (one should be a diuretic, unless subject has a documented intolerance to diuretics) at maximally tolerated doses and have had no changes to the medication regimen two (2) weeks prior to enrollment;
5. Subjects with a eGFR * 45 ml/min per 1.73m²;
6. Subjects who are willing and able to comply with all study procedures.;Anatomical Inclusion Criteria:
1. Subjects, with or without an accessory renal artery, with a main renal artery diameter of * 3.5 mm and * 7.0 mm for each of their kidneys.
2. Subject with a main renal artery without significant stenosis (stenosis defined as < 30%).
3. Subjects with a renal artery length of * 15 mm.
Exclusion criteria
1. Subjects with secondary hypertension;
2. Subjects who are contraindicated for intravascular contrast material;
3. Subjects who are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure;
4. Subjects with known bleeding or hyper-coagulation disorders;
5. Subjects who have type 1 diabetes mellitus;
6. Subjects who have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques;
7. Subjects who have planned percutaneous vascular or surgical intervention for any reason within the next 6 months;
8. Subjects who have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous;
9. Subjects who have an implantable cardioverter defibrillator (ICD) or pacemaker or
abnormal electrocardiogram at time of screening;
10. Subjects who have any serious medical condition, which in the opinion of the investigator, may adversely affect patient safety or the efficacy of the procedure in the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders);
11. Subjects who are pregnant, nursing or planning to become pregnant or who are currently taking estrogen or any estrogen-like compound (female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to the procedure);
12. Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency;
13. Subjects who are currently enrolled in any investigational study wherein patient participation has not been completed;
14. Subjects who, for any reason, may not be able to understand or comply with instructions; ;Anatomical Exclusion Criteria:
1. Subjects with only one kidney;
2. Subjects with prior renal denervation procedure;
3. Subjects with prior intervention to right or left renal artery;
4. Subjects with renal artery stenosis as defined by * 30% stenosis confirmed by angiography with two (2) orthogonal views with selective catheterization;
5. Subjects with iliac stenosis requiring intervention at time of procedure and/or within the next six (6) months;
6. Subjects with severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure;
7. Subjects in which the physician is unable to cannulate the renal artery;
8. Subjects in which the physician is unable to access the femoral artery by percutaneous means.
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 | NCT01541865 |
| CCMO | NL39063.018.12 |