Trials / Completed
CompletedNCT02920034
Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension
A Randomized Comparison of Ultrasound Based Versus Radiofrequency Based Catheter Ablation Techniques in Patients With Therapy Resistant Arterial Hypertension With Large Renal Arteries
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Heart Center Leipzig - University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, randomized trial to assess the effectiveness of different renal sympathetic denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a cohort of patients with therapy refractory arterial hypertension and large renal arteries
Detailed description
The aim of this trial is a prospective, randomized comparison of three different techniques for catheter based renal sympathetic denervation. Patients with larger (\>5.5 mm) renal arteries are randomized to a treatment with a radiofrequency based catheter of the main renal artery, the main renal artery, its side-branches and accessories or an ultrasound-based denervation of the main renal artery only. The primary endpoint is the change in daytime blood pressure acquired in ambulatory blood pressure measurement at 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Radiofrequency denervation of the main renal arteries | Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA) |
| DEVICE | Radiofrequency denervation of renal arteries and branches | Catheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA) |
| DEVICE | Ultrasound denervation of the main renal arteries | Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA) |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2018-09-01
- Completion
- 2020-06-01
- First posted
- 2016-09-30
- Last updated
- 2021-05-24
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02920034. Inclusion in this directory is not an endorsement.