Clinical trials: Renal Denervation
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.
Hypertension, Hypertension,Essential
The TARGET BP OFF-MED Trial
To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.
- Trial name
- NCT03503773
- Testing
- Alcohol
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 350 people
- Sponsor
- Ablative Solutions, Inc.
Uncontrolled Hypertension
EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension
The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.
- Trial name
- NCT01996033
- Where
- 12 sites in Germany
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
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.
Hypertension
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.
- Trial name
- EnligHTN-I (NCT01438229)
- Testing
- St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
- Where
- 4 sites in Australia, Greece
- Volunteers
- 47 people
- Sponsor
- Abbott Medical Devices
Hypertension, Vascular Diseases
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Trial name
- NCT02439749
- Testing
- Symplicity Spyral™ multi-electrode renal denervation system
- Where
- 47 sites in United States, Australia and 7 more
- Volunteers
- 366 people
- Sponsor
- Medtronic Vascular
Hypertension
EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension
The purpose of the EnligHTN IV clinical investigation is to demonstrate the safety and effectiveness of the EnligHTN™ Renal Denervation System in the treatment of subjects with drug-resistant uncontrolled hypertension.
- Trial name
- EnligHTN-IV (NCT01903187)
- Testing
- EnligHTN Renal Denervation
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Abbott Medical Devices
Uncontrolled Hypertension
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.
- Trial name
- HTN-2 (NCT00888433)
- Testing
- Renal Denervation (Symplicity® Renal Denervation System)
- Where
- 20 sites in Australia, Austria and 8 more
- Volunteers
- 106 people
- Sponsor
- Medtronic Vascular
Hypertension
The Peregrine Post-Market Study for the Treatment of Hypertension
The Ablative Solutions, Inc. Peregrine System Infusion Catheter is a catheter-based device which is intended to be used to ablate the afferent and efferent sympathetic nerves serving the kidneys.
- Trial name
- NCT02570113
- Testing
- Peregrine System Infusion Catheter
- Where
- 10 sites in Belgium, Czechia and 2 more
- Volunteers
- 45 people
- Sponsor
- Ablative Solutions, Inc.
Hypertension
Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)
The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and…
- Trial name
- NCT02392351
- Testing
- Renal Denervation (Vessix), Renal Angiography
- Where
- 12 sites in United States
- Volunteers
- 51 people
- Sponsor
- Boston Scientific Corporation
Hypertension, Vascular Diseases
SPYRAL DYSTAL Renal Denervation Global Clinical Study
The objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure as the procedural approach…
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Trial name
- NCT04311086
- Testing
- Renal Denervation (Symplicity Spyral™)
- Where
- 8 sites in United States, Germany and 2 more
- Volunteers
- 128 people
- Sponsor
- Medtronic Vascular
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
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved…
- Conditions
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
- Trial name
- RDN+AF (NCT01907828)
- Testing
- Renal Artery Ablation, Cardiac Ablation
- Where
- 2 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Abbott Medical Devices
Hypertension, Blood Pressure
IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.
- Trial name
- EnligHTN-II (NCT01705080)
- Testing
- EnligHTN
- Where
- 33 sites in Australia, France and 9 more
- Volunteers
- 276 people
- Sponsor
- Abbott Medical Devices
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
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter
The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation…
- Trial name
- REDUCE-HTN (NCT01541865)
- Testing
- Renal Denervation
- Where
- 26 sites in Australia, Austria and 6 more
- Volunteers
- 146 people
- Sponsor
- Boston Scientific Corporation
Uncontrolled Hypertension
Observational Study of the EnligHTN Renal Denervation System in Europe
The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.
- Trial name
- NCT02006758
- Testing
- EnligHTN™ Renal Denervation System
- Where
- 13 sites in Belgium, Estonia and 4 more
- Volunteers
- 68 people
- Sponsor
- Abbott Medical Devices