ClinicalTrials.gg
Status unknownNCT02690909Updated May 11, 2016

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

An interventional study of Redy™ Renal Denervation System in Hypertension Resistant to Conventional Therapy, sponsored by Renal Dynamics GmbH. Status unknown at 10 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-11.

Sponsored by Renal Dynamics GmbH · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension Resistant to Conventional Therapy

Keywords

  • Uncontrolled Hypertension
  • Resistant Hypertension
  • Renal Denervation
03

In context

Lead sponsor

This is the only study on the registry with Renal Dynamics GmbH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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);
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Redy™ Renal Denervation System

    Renal Denervation System

    Device: Redy™ Renal Denervation System

Interventions

  • DeviceRedy™ Renal Denervation System

    Renal Denervation System

06

What researchers measure

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

    Time frame: 1-month post treatment

Secondary outcomes

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

    Incidence of peri-procedural Adverse Events at 1-month follow-up post treatment

    Time frame: 1-month post treatment

  2. 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

    Time frame: 3 and 6 months post treatment

  3. 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

    Time frame: 3 months post treatment

  4. 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

    Time frame: 1, 3 and 6 months post treatment

  5. 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

    Time frame: 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

    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

07

Study locations

3 of 10 sites recruiting
  • OLV Onze-Lieve-Vrouwziekenhuis
    Aalst, Belgium
    Not yet recruiting
    • Eric Wyffels, Dr. · Contact
    • William Wijns, Dr. · Contact
  • ZNA Middelheim Hospital
    Antwerp, Belgium
    Not yet recruiting
    • Stefan Verheye, Dr. · Contact
  • Asklepios Klinik St. Georg
    Hamburg, Germany
    Not yet recruiting
    • Felix Meincke, Dr. · Contact
    • Karl-Heinz Kuck, Prof. Dr. · Contact
  • Saarland University Medical Center
    Homburg, Germany
    Not yet recruiting
    • Felix Mahfoud, PD Dr. · Contact
    • Hans Maurer, Prof. Dr. · Contact
  • Semmelweis University
    Budapest, Hungary
    Not yet recruiting
    • Bela Merkely, Prof. Dr. · Contact
    • Peter Perge, Dr. · Contact
  • Galway University Hospital
    Galway, Ireland
    Not yet recruiting
    • Faisal Sharif, Dr. · Contact
  • Kaplan Medical Center
    Rehovot, Israel
    Recruiting
    • Michael Jonas, Dr. · Contact
  • The Cardinal Stefan Wyszyński Institute of Cardiology
    Warsaw, Poland
    Recruiting
    • Adam Witkowski, Prof. Dr. · Contact
  • Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology
    Novosibirsk, Russia
    Recruiting
    • Evgeny Pokushalov, Dr. · Contact
  • KCS Clinical Center of Serbia
    Belgrade, Serbia
    Not yet recruiting
    • Goran Stankovic, Dr. · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02690909
Lead sponsor
Renal Dynamics GmbH
Collaborators
Biosensors Europe SA, Physio-Logic Ltd. Israel, AmeRuss Clinical Trials LLC, USA
Responsible party
Sponsor
First posted
Feb 24, 2016
Start date
Apr 2016
Primary completion
Apr 2017 (estimated)
Completion
Aug 2017 (estimated)
Last update
May 11, 2016

Study contacts

Erifyli Kalloudi
Contact
e.kalloudi@biosensors.com
+41(0)218048000 ext. 143
Norbert Clemens, MD, PhD
Contact
norbert.clemens@renal-dynamics.com
+491714073000
Felix Mahfoud, MD
principal investigator · Saarland University Medical Center Homburg, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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