N/A
N=47
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01438229 ↗Enrolled (actual)
47
Serious AEs
30.4%
Results posted
May 2015
Primary outcome: Primary: Adverse Events — 47.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
47.8 | — |
| PRIMARY Office Systolic Blood Pressure Change |
-26 | <0.0001 sig |
Summary
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.
Eligibility Criteria
Inclusion Criteria
- Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
- Age ≥18 and ≤80 years old
- Able and willing to provide written informed consent to participate in the study
- Able and willing to comply with the required follow-up schedule
Exclusion Criteria
- Prior renal artery intervention (balloon angioplasty or stenting)
- Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery
- Multiple main renal arteries in either kidney
- Main renal arteries <4 mm in diameter or <20 mm in length
- eGFR of <45 mL/min per 1.73 m2 using the MDRD formula
- Type 1 diabetes
- Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
- Others
Data sourced from ClinicalTrials.gov (NCT01438229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.