Clinical trial NCT02690909: A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
Official title: A Prospective, Post-marketing, Single-arm, Open Label, Multi-center Clinical Study to Evaluate the Safety and Efficacy of the ReDy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension Resistant to Conventional Therapy
Keywords: Uncontrolled Hypertension
Resistant Hypertension
Renal Denervation
Lead sponsor: Renal Dynamics GmbH
Sponsor class: INDUSTRY
Collaborators: name: Biosensors Europe SA
name: Physio-Logic Ltd. Israel
name: AmeRuss Clinical Trials LLC, USA
First posted: 2016-02-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries.

This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled hypertension.


Eligibility criteria: Inclusion criteria:

1. Patient has established hypertension (diagnosed ≥12 months prior to screening) and is on a guideline based stable drug regimen (≥ 4 weeks), consisting of ≥3 anti-hypertensive medications of different classes including a diuretic;
2. Office systolic blood pressure \>150 mmHg;
3. Patient has (under directly observed therapy) average daytime systolic blood pressure values \> 140 mmHg by 24h ambulatory blood pressure monitoring;
4. Patient is ≥ 18 and ≤ 75 years of age at time of consent;
5. Patient must be able and willing to comply with the required follow-up schedule;
6. Patient must be able and willing to provide written informed consent;

Exclusion criteria:

1. Patient has known significant reno-vascular abnormalities such as renal artery stenosis \> 30%;
2. Patient has "Isolated Systolic Hypertension" with a diastolic blood pressure \< 90 mmHg;
3. Evidence or history of secondary hypertension, other than sleep apnea syndrome;
4. Patient has a history of prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent graft placement;
5. Patient has significant valvular heart disease;
6. Patient has known coagulation abnormalities;
7. Patient life expectancy is \< 12 months, as estimated by the study Investigator;
8. Patient is participating in another clinical study, which is before its primary endpoint and/or has the potential to impact his/her hypertension management (pharmaceutical / device);
9. Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods;
10. Patient has active systemic infection;
11. Patient has small \<4.0 mm in diameter, large \>6.5 mm in diameter or short \<20.0 mm in length, multiple main, or highly tortuous renal arteries;
12. Patient has impaired renal function with an estimated GFR \<45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula;
13. Patient had a renal transplant or is awaiting a renal transplant;
14. Patient has a known intolerance for x-ray contrast agent that cannot be adequately controlled with pre-medication;
15. Any medical condition as estimated by the Study Investigator that may harm patient or jeopardize study participation, the interpretation of study results or may impede the ability to obtain informed consent (e.g., mental condition);

Primary outcomes:
measure: Device-related adverse events at 1-month follow-up post treatment
timeFrame: 1-month post treatment
Secondary outcomes:
measure: Peri-procedural Adverse Events at 1-month follow-up post treatment
timeFrame: 1-month post treatment
measure: Device-related Adverse Events at 3 and 6 months follow-up post treatment
timeFrame: 3 and 6 months post treatment
measure: Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months
timeFrame: 3 months post treatment
measure: Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment
timeFrame: 1, 3 and 6 months post treatment
measure: Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment
timeFrame: 1, 3 and 6 months post treatment
measure: Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment
timeFrame: 1, 3 and 6 months post treatment
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Onze-Lieve-Vrouwziekenhuis
city: Antwerpen
country: Belgium
facility: ZNA Middelheim Hospital
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Homburg
country: Germany
facility: Saarland University Medical Center
city: Budapest
country: Hungary
facility: Semmelweis University
city: Galway
country: Ireland
facility: Galway University Hospital
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszyński Institute of Cardiology
city: Novosibirsk
country: Russian Federation
facility: Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology
city: Belgrade
country: Serbia
facility: KCS Clinical Center of Serbia
Study officials:
affiliation: Saarland University Medical Center Homburg, Germany
name: Felix Mahfoud, MD
role: PRINCIPAL_INVESTIGATOR
References: