Trials / Unknown
UnknownNCT01522430
Study of Catheter Based Renal Denervation Therapy in Hypertension
DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Erasme University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation: 1. reduces daytime ambulatory blood pressure, 2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Renal angiography followed by renal sympathetic denervation | Radiofrequency catheter based therapy for renal denervation: Symplicity catheter will be advanced into the renal artery and connected to a radiofrequency generator. As previously described, four-to-six discrete, low-power radio frequency treatments will be applied along the length of both main renal arteries. At least four radiofrequency applications will be delivered in each renal artery, unless this is not feasible for anatomical reasons. |
| PROCEDURE | Renal angiography alone | Procedure will start with a local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery, which allows a minimal risk of bleeding to the patient. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized. |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2014-12-01
- Completion
- 2016-12-01
- First posted
- 2012-01-31
- Last updated
- 2012-01-31
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01522430. Inclusion in this directory is not an endorsement.