The aim of the study is to evaluate the safety of the Flex catheter and the effect of the renal denervation on blood pressure.
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To demonstrate that renal denervation achieved via the delivery of RF energy
is safe, and not associated with clinically significant adverse events.
Secondary outcome
To document the physiologic effects of denervation in patients with refractory
hypertension.
To determine whether renal denervation contributes to hypertension control.
To determine whether renal denervation improves renal function
To determine whether renal denervation contributes to improvement of glucose
management in patients with abnormal baseline Hemoglobin A1c
To assess the performance of the Ardian Symplicity Catheter System
Background summary
A set of pre-clinical studies have shown that renal denervation will decrease
blood pressure. The System delivers low-level radiofrequency energy through the
wall of the renal artery to denervate the human kidney. The catheter is
introduced using standard interventional technique via the femoral artery, and
is positioned in the renal artery under fluoroscopic guidance.The treatment
involves the delivery of relatively low-power and precisely focused RF bursts
of approximately 8W (contrasted with cardiovascular RF devices that generally
operate in excess of 30W) through the wall of the renal artery to disrupt the
surrounding renal nerves lying in the adventitia.
Study objective
The aim of the study is to evaluate the safety of the Flex catheter and the
effect of the renal denervation on blood pressure.
Study design
The study is a non-randomized, open-label post-market clinical follow-up study
to collect additional data on the safety and physiologic response of renal
denervation in patients with refractory hypertension. This study will enroll up
to one-hundred (100) participants at up to ten (10) research sites.
Intervention
The treatment involves the delivery of relatively low-power and precisely
focused RF bursts of approximately 8W (contrasted with cardiovascular RF
devices that generally operate in excess of 30W) through the wall of the renal
artery to disrupt the surrounding renal nerves lying in the adventitia.
Study burden and risks
Risks associated to the procedure is extensively discussed in section E9. The
burden for the participants: The procedure will take about an hour. Then the
patients will be asked to visit the hospital 3 days, 1, 3, 6, 12, 18, 24 and 36
months (these visits will be combined to their regular visits of our
out-patient clinic).
1810A Embarcadero Road
Palo Alto, CA 94303
USA
1810A Embarcadero Road
Palo Alto, CA 94303
USA
Listed location countries
Age
Inclusion criteria
. Individual has a systolic blood pressure higher than 160 mmHg (higher than 150 mmHg for type 2 diabetics). 2. Individual is adhering to a stable drug regimen including 3 or more antihypertensive medications (with no changes for a minimum of 2 weeks prior to enrollment) that is expected to be maintained for at least 6 months. 3. Individual is >=18 and <= 85 years of age.
Exclusion criteria
. Individual has anatomically abnormal renal artery (this is defined in detail in the study protocol on page 13). 2. Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2 3. Individual has type 1 diabetes mellitus. 4. Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months from the screening visit, or has widespread atherosclerosis. 5. Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months. 6. Individual has hemodynamically significant valvular heart disease. 7. Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with MRI. 8. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study. 9. Individual is pregnant, nursing or planning to be pregnant. 10. Individual has a known, unresolved history of drug use or alcohol dependency. 11. Individual is currently enrolled in another investigational drug or device trial.
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 | NL31384.041.10 |
| Other | volgt nog |