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

NCT02690909 | Unknown

• 1 other identifier: RD1501
• Study Type: interventional
• Target: 55
• Locations: 8 countries
• Sites: 10

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

Keywords

Uncontrolled Hypertension; Resistant Hypertension; Renal Denervation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Peri-procedural Adverse Events at 1-month follow-up post treatment

  1-month post treatment

• Device-related Adverse Events at 3 and 6 months follow-up post treatment

  3 and 6 months post treatment

• Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months

  3 months post treatment

• Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment

  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

Study Arms (1)

Redy™ Renal Denervation System

EXPERIMENTAL

Renal Denervation System

Device: Redy™ Renal Denervation System

Interventions

Redy™ Renal Denervation System DEVICE

Renal Denervation System

Redy™ Renal Denervation System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Office systolic blood pressure \>150 mmHg;
• Patient has (under directly observed therapy) average daytime systolic blood pressure values \> 140 mmHg by 24h ambulatory blood pressure monitoring;
• Patient is ≥ 18 and ≤ 75 years of age at time of consent;
• Patient must be able and willing to comply with the required follow-up schedule;
• Patient must be able and willing to provide written informed consent;

You may not qualify if:

• Patient has known significant reno-vascular abnormalities such as renal artery stenosis \> 30%;
• Patient has "Isolated Systolic Hypertension" with a diastolic blood pressure \< 90 mmHg;
• Evidence or history of secondary hypertension, other than sleep apnea syndrome;
• Patient has a history of prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent graft placement;
• Patient has significant valvular heart disease;
• Patient has known coagulation abnormalities;
• Patient life expectancy is \< 12 months, as estimated by the study Investigator;
• 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);
• Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods;
• Patient has active systemic infection;
• 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;
• 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;
• Patient had a renal transplant or is awaiting a renal transplant;
• Patient has a known intolerance for x-ray contrast agent that cannot be adequately controlled with pre-medication;
• 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);

Sponsors & Collaborators

• Renal Dynamics GmbH: lead
• Biosensors Europe SA: collaborator
• Physio-Logic Ltd. Israel: collaborator
• AmeRuss Clinical Trials LLC, USA: collaborator

Study Sites (10)

OLV Onze-Lieve-Vrouwziekenhuis

Aalst, Belgium

NOT YET RECRUITING

ZNA Middelheim Hospital

Antwerp, Belgium

NOT YET RECRUITING

Asklepios Klinik St. Georg

Hamburg, Germany

NOT YET RECRUITING

Saarland University Medical Center

Homburg, Germany

NOT YET RECRUITING

Semmelweis University

Budapest, Hungary

NOT YET RECRUITING

Galway University Hospital

Galway, Ireland

NOT YET RECRUITING

Kaplan Medical Center

Rehovot, Israel

RECRUITING

The Cardinal Stefan Wyszyński Institute of Cardiology

Warsaw, Poland

RECRUITING

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

Novosibirsk, Russia

RECRUITING

KCS Clinical Center of Serbia

Belgrade, Serbia

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Officials

• Felix Mahfoud, MD

  Saarland University Medical Center Homburg, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erifyli Kalloudi

CONTACT

+41(0)218048000; e.kalloudi@biosensors.com

Norbert Clemens, MD, PhD

CONTACT

+491714073000; norbert.clemens@renal-dynamics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: February 24, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 11, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); PL (1); SE (1); BE (2); HU (1); IE (1); RU (1); IL (1)