Clinical trials: Renal Denervation
Hypertension
Sham Controlled Study of Renal Denervation for Untreated Stage I and II Hypertension
The Wave VI study is a, multicenter, prospective, double-blind, randomized, sham controlled feasibility study of the safety of renal denervation in patients with stage I and II hypertension who have an average office systolic…
- Trial name
- NCT02480517
- Testing
- Ultrasound
- Volunteers
- 60 people
- Sponsor
- Kona Medical Inc.
Uncontrolled Essential Hypertension
Ultrasound Ablation for Essential Hypertension（FIM）
To evaluate the safety and feasibility of disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument in the treatment of essential hypertension.
- Trial name
- NCT05795829
- Testing
- disposable intravascular ultrasound ablation catheter and ultrasound ablation instrument
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
End Stage Renal Disease
Native Kidney Denervation in Patients With End Stage Renal Disease
To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).
- Trial name
- NCT00551304
- Testing
- Ardian Catheter
- Where
- 2 sites in Australia, Poland
- Sponsor
- Medtronic Vascular
Hypertension, Renal Denervation
International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension
The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant…
- Trial name
- EnligHTN III (NCT01836146)
- Testing
- EnligHTN™ Renal Artery Ablation Catheter
- Where
- 6 sites in Australia, New Zealand
- Volunteers
- 39 people
- Sponsor
- Abbott Medical Devices
Hypertension, Renal
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157
This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.
- Trial name
- RENABLATE-II (NCT02095691)
- Testing
- Celsius® ThermoCool® Renal Denervation
- Volunteers
- 19 people
- Sponsor
- Biosense Webster, Inc.
Resistant Hypertension
REnAL denervatIon by ultraSound Transcatheter Emission
The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.
- Trial name
- REALISE (NCT01529372)
- Testing
- PARADISE percutaneous renal denervation
- Where
- 2 sites in France
- Volunteers
- 20 people
- Sponsor
- ReCor Medical, Inc.
Hypertension, Vascular Diseases
SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System
The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Trial name
- NCT02439775
- Testing
- Symplicity Spyral™ multi-electrode renal denervation system
- Where
- 56 sites in United States, Australia and 8 more
- Volunteers
- 337 people
- Sponsor
- Medtronic Vascular
Hypertension, Resistant to Conventional Therapy
Rapid Renal Sympathetic Denervation for Resistant Hypertension
The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.
- Trial name
- RAPID (NCT01520506)
- Testing
- Covidien OneShot™ System
- Where
- 14 sites in Belgium, Germany and 4 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
Hypertension
A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension
This study is a prospective, single-institution trial wherein twenty subjects with refractory hypertension will receive the experimental focused ultrasound renal denervation therapy.
- Trial name
- NCT01638195
- Testing
- Focused Ultrasound
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Kona Medical Inc.
Hypertension
Sympathetic Mapping/ Ablation of Renal Nerves Trial
To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I® and SYMPIONEER S1® Stimulator/ Generator in patients with essential hypertension for at least 6 months of the disease history and…
- Trial name
- SMART (NCT02761811)
- Testing
- SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator
- Where
- 15 sites in China
- Volunteers
- 220 people
- Sponsor
- SyMap Medical (Suzhou), Ltd.
Hypertension, Vascular Diseases
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective…
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- SWYFT (NCT07115953)
- Testing
- Symplicity Spyral™ multi-electrode renal denervation system
- Where
- 21 sites in Australia, Belgium and 7 more
- Volunteers
- 130 people
- Sponsor
- Medtronic Vascular
Hypertension, Renal
RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension
The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational multi-electrode ablation catheter and integrated ablation system to…
- Trial name
- NCT01756300
- Testing
- Celsius® ThermoCool® RD
- Volunteers
- 35 people
- Sponsor
- Biosense Webster, Inc.
Chronic Heart Failure
Clinical Study of an Ultrasound Renal Denervation System in Patients With Heart Failure
The purpose is to evaluate the renal denervation system (PRDS-001) for controlling sympathetic nerve over-activation in patients with heart failure, and for its safety in such patients.
- Trial name
- NCT04719637
- Testing
- PRDS-001 Renal Denervation Ultrasound System
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Otsuka Medical Devices Co., Ltd. Japan
Hypertension
TARGET BP I Clinical Trial
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group…
- Trial name
- TARGET BP I (NCT02910414)
- Testing
- Dehydrated alcohol
- Where
- 5 sites in United States
- Volunteers
- 300 people
- Sponsor
- Ablative Solutions, Inc.
Metabolic Syndrome
Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)
The purpose of this clinical investigation is to determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity in patients with metabolic syndrome.
- Trial name
- NCT01911078
- Testing
- Renal Denervation, EnligHTN™ Renal Denervation System.
- Where
- Greece
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Hypertension, Vascular Diseases
DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive Medications
The objective of this study is to evaluate the safety and effectiveness of renal denervation using DENEX System in patients with hypertension without antihypertensive medication, compared with the sham group.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Trial name
- NCT04535050
- Testing
- Renal denervation, Renal angiography
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- Kalos Medical
Hypertension
Renal Denervation for the Treatment of Hypertension: A Pilot Safety and Efficacy Study
A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension.
- Trial name
- NCT02672462
- Testing
- Radio frequency renal denervation system (Golden Leaf GL-06E15A)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
Hypertension
Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound
This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy.
- Trial name
- NCT01704170
- Testing
- Kona Externally Focused Ultrasound Therapy
- Where
- 4 sites in Australia, Canada and 1 more
- Volunteers
- 31 people
- Sponsor
- Kona Medical Inc.
Hypertension
Renal Denervation Using Externally Focused Therapeutic Ultrasound
This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.
- Trial name
- NCT01926951
- Testing
- Surround Sound Externally Focused Therapeutic Ultrasound
- Where
- 3 sites in Czechia, New Zealand
- Volunteers
- 27 people
- Sponsor
- Kona Medical Inc.
Atrial Fibrillation, Hypertension
Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation
The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a…
- Trial name
- Symplicity AF (NCT02064764)
- Testing
- Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Arctic Front Advance™ Cardiac Cryoablation System
- Where
- 10 sites in United States, Germany
- Volunteers
- 102 people
- Sponsor
- Medtronic Vascular