A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension

Hypertension Resistant to Conventional Therapy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02690909
• Other study ID #: RD1501
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2016
• Last updated: May 10, 2016
• Start date: April 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2016
• Source: Renal Dynamics GmbH
• Contact: Erifyli Kalloudi
• Phone: +41(0)218048000
• Email: e.kalloudi[@]biosensors.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: August 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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);

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension Resistant to Conventional Therapy

Intervention

Device:
• Redy™ Renal Denervation System
Renal Denervation System

Locations

Country	Name	City	State
Belgium	OLV Onze-Lieve-Vrouwziekenhuis	Aalst
Belgium	ZNA Middelheim Hospital	Antwerpen
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Saarland University Medical Center	Homburg
Hungary	Semmelweis University	Budapest
Ireland	Galway University Hospital	Galway
Israel	Kaplan Medical Center	Rehovot
Poland	The Cardinal Stefan Wyszynski Institute of Cardiology	Warsaw
Russian Federation	Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology	Novosibirsk
Serbia	KCS Clinical Center of Serbia	Belgrade

Sponsors (4)

Lead Sponsor	Collaborator
Renal Dynamics GmbH	AmeRuss Clinical Trials LLC, USA, Biosensors Europe SA, Physio-Logic Ltd. Israel

Countries where clinical trial is conducted

Belgium,  Germany,  Hungary,  Ireland,  Israel,  Poland,  Russian Federation,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-related adverse events at 1-month follow-up post treatment	Incidence of device-related Adverse Events at 1-month follow-up post treatment	1-month post treatment	Yes
Secondary	Peri-procedural Adverse Events at 1-month follow-up post treatment	Incidence of peri-procedural Adverse Events at 1-month follow-up post treatment	1-month post treatment	Yes
Secondary	Device-related Adverse Events at 3 and 6 months follow-up post treatment	Incidence of device-related Adverse Events at 3 and 6 months follow-up post treatment	3 and 6 months post treatment	Yes
Secondary	Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months	Reduction of average systolic daytime blood pressure as assessed by 24h ambulatory blood pressure monitoring at 3-month compared to baseline	3 months post treatment	No
Secondary	Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment	Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment	1, 3 and 6 months post treatment	No
Secondary	Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment	Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment	1, 3 and 6 months post treatment	No
Secondary	Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment	Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment	1, 3 and 6 months post treatment	No