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

NCT ID: NCT02690909

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-08-31

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.

Conditions

Hypertension Resistant to Conventional Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Redy™ Renal Denervation System

Renal Denervation System

Group Type: EXPERIMENTAL

Redy™ Renal Denervation System

Intervention Type: DEVICE

Renal Denervation System

Interventions

Redy™ Renal Denervation System

Renal Denervation System

Intervention Type: DEVICE

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosensors Europe SA

INDUSTRY

Sponsor Role: collaborator

Physio-Logic Ltd. Israel

UNKNOWN

Sponsor Role: collaborator

AmeRuss Clinical Trials LLC, USA

UNKNOWN

Sponsor Role: collaborator

Renal Dynamics GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felix Mahfoud, MD

Role: PRINCIPAL_INVESTIGATOR

Saarland University Medical Center Homburg, Germany

Locations

OLV Onze-Lieve-Vrouwziekenhuis

Aalst, , Belgium

Site Status: NOT_YET_RECRUITING

ZNA Middelheim Hospital

Antwerp, , Belgium

Site Status: NOT_YET_RECRUITING

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status: NOT_YET_RECRUITING

Saarland University Medical Center

Homburg, , Germany

Site Status: NOT_YET_RECRUITING

Semmelweis University

Budapest, , Hungary

Site Status: NOT_YET_RECRUITING

Galway University Hospital

Galway, , Ireland

Site Status: NOT_YET_RECRUITING

Kaplan Medical Center

Rehovot, , Israel

Site Status: RECRUITING

The Cardinal Stefan Wyszyński Institute of Cardiology

Warsaw, , Poland

Site Status: RECRUITING

Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status: RECRUITING

KCS Clinical Center of Serbia

Belgrade, , Serbia

Site Status: NOT_YET_RECRUITING

Countries

Belgium; Germany; Hungary; Ireland; Israel; Poland; Russia; Serbia

Central Contacts

Erifyli Kalloudi

Role: CONTACT

e.kalloudi@biosensors.com

+41(0)218048000 ext. 143

Norbert Clemens, MD, PhD

Role: CONTACT

norbert.clemens@renal-dynamics.com

+491714073000

Facility Contacts

Eric Wyffels, Dr.

Role: primary

William Wijns, Dr.

Role: backup

Stefan Verheye, Dr.

Role: primary

Felix Meincke, Dr.

Role: primary

Karl-Heinz Kuck, Prof. Dr.

Role: backup

Felix Mahfoud, PD Dr.

Role: primary

Hans Maurer, Prof. Dr.

Role: backup

Bela Merkely, Prof. Dr.

Role: primary

Peter Perge, Dr.

Role: backup

Faisal Sharif, Dr.

Role: primary

Michael Jonas, Dr.

Role: primary

Adam Witkowski, Prof. Dr.

Role: primary

Evgeny Pokushalov, Dr.

Role: primary

Goran Stankovic, Dr.

Role: primary

Other Identifiers

RD1501

Identifier Type: -

Identifier Source: org_study_id