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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02690909
Recruitment Status : Unknown
Verified May 2016 by Renal Dynamics GmbH.
Recruitment status was:  Recruiting
First Posted : February 24, 2016
Last Update Posted : May 11, 2016
Sponsor:
Collaborators:
Biosensors Europe SA
Physio-Logic Ltd. Israel
AmeRuss Clinical Trials LLC, USA
Information provided by (Responsible Party):
Renal Dynamics GmbH

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertension Resistant to Conventional Therapy Device: Redy™ Renal Denervation System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Redy™ Renal Denervation System
Renal Denervation System
 Device: Redy™ Renal Denervation System
Renal Denervation System


Outcome Measures
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Primary Outcome Measures :
  1. Device-related adverse events at 1-month follow-up post treatment [ Time Frame: 1-month post treatment ]
    Incidence of device-related Adverse Events at 1-month follow-up post treatment


Secondary Outcome Measures :
  1. Peri-procedural Adverse Events at 1-month follow-up post treatment [ Time Frame: 1-month post treatment ]
    Incidence of peri-procedural Adverse Events at 1-month follow-up post treatment

  2. Device-related Adverse Events at 3 and 6 months follow-up post treatment [ Time Frame: 3 and 6 months post treatment ]
    Incidence of device-related Adverse Events at 3 and 6 months follow-up post treatment

  3. Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months [ Time Frame: 3 months post treatment ]
    Reduction of average systolic daytime blood pressure as assessed by 24h ambulatory blood pressure monitoring at 3-month compared to baseline

  4. Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
    Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment

  5. Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
    Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment

  6. Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690909


Contacts
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Contact: Erifyli Kalloudi +41(0)218048000 ext 143 e.kalloudi@biosensors.com
Contact: Norbert Clemens, MD, PhD +491714073000 norbert.clemens@renal-dynamics.com

Locations
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Belgium
OLV Onze-Lieve-Vrouwziekenhuis Not yet recruiting
Aalst, Belgium
Contact: Eric Wyffels, Dr.         
Contact: William Wijns, Dr.         
ZNA Middelheim Hospital Not yet recruiting
Antwerpen, Belgium
Contact: Stefan Verheye, Dr.         
Germany
Asklepios Klinik St. Georg Not yet recruiting
Hamburg, Germany
Contact: Felix Meincke, Dr.         
Contact: Karl-Heinz Kuck, Prof. Dr.         
Saarland University Medical Center Not yet recruiting
Homburg, Germany
Contact: Felix Mahfoud, PD Dr.         
Contact: Hans Maurer, Prof. Dr.         
Hungary
Semmelweis University Not yet recruiting
Budapest, Hungary
Contact: Bela Merkely, Prof. Dr.         
Contact: Peter Perge, Dr.         
Ireland
Galway University Hospital Not yet recruiting
Galway, Ireland
Contact: Faisal Sharif, Dr.         
Israel
Kaplan Medical Center Recruiting
Rehovot, Israel
Contact: Michael Jonas, Dr.         
Poland
The Cardinal Stefan Wyszyński Institute of Cardiology Recruiting
Warsaw, Poland
Contact: Adam Witkowski, Prof. Dr.         
Russian Federation
Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation
Contact: Evgeny Pokushalov, Dr.         
Serbia
KCS Clinical Center of Serbia Not yet recruiting
Belgrade, Serbia
Contact: Goran Stankovic, Dr.         
Sponsors and Collaborators
Renal Dynamics GmbH
Biosensors Europe SA
Physio-Logic Ltd. Israel
AmeRuss Clinical Trials LLC, USA
Investigators
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Principal Investigator: Felix Mahfoud, MD Saarland University Medical Center Homburg, Germany
More Information
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Responsible Party: Renal Dynamics GmbH
ClinicalTrials.gov Identifier: NCT02690909    
Other Study ID Numbers: RD1501
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Renal Dynamics GmbH:
Uncontrolled Hypertension
Resistant Hypertension
Renal Denervation
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases