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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension Resistant to Conventional Therapy
• Intervention / Treatment: Device: Redy™ Renal Denervation System

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Not yet recruiting
    • OLV Onze-Lieve-Vrouwziekenhuis
    • Contact: Eric Wyffels, Dr.
    • Contact: William Wijns, Dr.
  • Antwerpen, Belgium
    • Not yet recruiting
    • ZNA Middelheim Hospital
    • Contact: Stefan Verheye, Dr.
• Germany
  • Hamburg, Germany
    • Not yet recruiting
    • Asklepios Klinik St. Georg
    • Contact: Felix Meincke, Dr.
    • Contact: Karl-Heinz Kuck, Prof. Dr.
  • Homburg, Germany
    • Not yet recruiting
    • Saarland University Medical Center
    • Contact: Felix Mahfoud, PD Dr.
    • Contact: Hans Maurer, Prof. Dr.
• Hungary
  • Budapest, Hungary
    • Not yet recruiting
    • Semmelweis University
    • Contact: Bela Merkely, Prof. Dr.
    • Contact: Peter Perge, Dr.
• Ireland
  • Galway, Ireland
    • Not yet recruiting
    • Galway University Hospital
    • Contact: Faisal Sharif, Dr.
• Israel
  • Rehovot, Israel
    • Recruiting
    • Kaplan Medical Center
    • Contact: Michael Jonas, Dr.
• Poland
  • Warsaw, Poland
    • Recruiting
    • The Cardinal Stefan Wyszynski Institute of Cardiology
    • Contact: Adam Witkowski, Prof. Dr.
• Russian Federation
  • Novosibirsk, Russian Federation
    • Recruiting
    • Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology
    • Contact: Evgeny Pokushalov, Dr.
• Serbia
  • Belgrade, Serbia
    • Not yet recruiting
    • KCS Clinical Center of Serbia
    • Contact: Goran Stankovic, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Redy™ Renal Denervation System; Renal Denervation System	Device: Redy™ Renal Denervation System; Renal Denervation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Renal Dynamics GmbH
• Collaborators: Biosensors Europe SA; Physio-Logic Ltd. Israel; AmeRuss Clinical Trials LLC, USA
• Investigators: Principal Investigator: Felix Mahfoud, MD, Saarland University Medical Center Homburg, Germany

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Uncontrolled Hypertension; Resistant Hypertension; Renal Denervation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: RD1501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No