A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Redy™ Renal Denervation System Renal Denervation System |
Device: Redy™ Renal Denervation System
Renal Denervation System
|
Outcome Measures
Primary Outcome Measures
- Device-related adverse events at 1-month follow-up post treatment [1-month post treatment]
Incidence of device-related Adverse Events at 1-month follow-up post treatment
Secondary Outcome Measures
- Peri-procedural Adverse Events at 1-month follow-up post treatment [1-month post treatment]
Incidence of peri-procedural Adverse Events at 1-month follow-up post treatment
- Device-related Adverse Events at 3 and 6 months follow-up post treatment [3 and 6 months post treatment]
Incidence of device-related Adverse Events at 3 and 6 months follow-up post treatment
- Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months [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
- Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment [1, 3 and 6 months post treatment]
Reduction of office systolic 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]
Reduction of office diastolic blood pressure 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]
Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment
Eligibility Criteria
Criteria
Inclusion criteria:
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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;
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Office systolic blood pressure >150 mmHg;
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Patient has (under directly observed therapy) average daytime systolic blood pressure values > 140 mmHg by 24h ambulatory blood pressure monitoring;
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Patient is ≥ 18 and ≤ 75 years of age at time of consent;
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Patient must be able and willing to comply with the required follow-up schedule;
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Patient must be able and willing to provide written informed consent;
Exclusion criteria:
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Patient has known significant reno-vascular abnormalities such as renal artery stenosis > 30%;
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Patient has "Isolated Systolic Hypertension" with a diastolic blood pressure < 90 mmHg;
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Evidence or history of secondary hypertension, other than sleep apnea syndrome;
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Patient has a history of prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent graft placement;
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Patient has significant valvular heart disease;
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Patient has known coagulation abnormalities;
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Patient life expectancy is < 12 months, as estimated by the study Investigator;
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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);
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Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods;
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Patient has active systemic infection;
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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;
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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;
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Patient had a renal transplant or is awaiting a renal transplant;
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Patient has a known intolerance for x-ray contrast agent that cannot be adequately controlled with pre-medication;
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OLV Onze-Lieve-Vrouwziekenhuis | Aalst | Belgium | ||
| 2 | ZNA Middelheim Hospital | Antwerpen | Belgium | ||
| 3 | Asklepios Klinik St. Georg | Hamburg | Germany | ||
| 4 | Saarland University Medical Center | Homburg | Germany | ||
| 5 | Semmelweis University | Budapest | Hungary | ||
| 6 | Galway University Hospital | Galway | Ireland | ||
| 7 | Kaplan Medical Center | Rehovot | Israel | ||
| 8 | The Cardinal Stefan Wyszyński Institute of Cardiology | Warsaw | Poland | ||
| 9 | Academician E.N. Meshalkin Novosibirsk State Research Institute of Circulation Pathology | Novosibirsk | Russian Federation | ||
| 10 | KCS Clinical Center of Serbia | Belgrade | Serbia |
Sponsors and Collaborators
- Renal Dynamics GmbH
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- RD1501