Recor
Menu
Am I a Candidate?

 

RADIANCE-HTN CLINICAL TRIAL

 

RADIANCE-HTN is a multicenter, blinded, randomized (1:1), sham-controlled trial to evaluate the use of the Paradise Ultrasound Renal Denervation System to reduce ambulatory blood pressure in patients with mild-moderate hypertension (SOLO Cohort) and resistant hypertension (TRIO Cohort).  Both cohorts were individually powered for efficacy with a primary endpoint of daytime systolic ambulatory blood pressure (ABP) at 2 months (2M).

The study was conducted at over 50 centers in 7 countries (United States, United Kingdom, France, Germany, Netherlands, Belgium, and Poland), and 282 subjects were randomized.

Significant Blood Pressure Reductions Achieved in Patients
with Mild-Moderate and Resistant Hypertension in the Absence of and Presence of Anti-hypertensive Medication

RADIANCE-HTN
Solo RESULTS

RADIANCE-HTN SOLO is a multicenter, international, blinded, randomised, sham-controlled trial to evaluate the use of the Paradise Ultrasound Renal Denervation System to reduce ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications.

Key Take-aways

The Paradise Ultrasound Renal Denervation System significantly lowered blood pressure in patients with mild-moderate hypertension and demonstrated:


Safety

  • No major adverse events within 30 days of the procedure
  • Positive safety profile through 12 months


efficacy

  • Greater reduction in daytime ambulatory systolic BP than a sham procedure
  • Consistent reductions in 24-hour ambulatory, office, and home BP
  • Over 2 out of 3 treated patients experienced at least a 5 mmHg decrease in daytime ambulatory BP. In those responders, the average drop was 13.6 mmHg


DURABILITY

  • Reduction in systolic ambulatory BP from baseline was stable between 6 and 12 months

 

The Paradise Ultrasound Renal Denervation System demonstrated safety, efficacy, and durability in patients with mild-moderate hypertension.

 

RADIANCE-HTN
TRIO RESULTS

RADIANCE-HTN TRIO is an international, multicenter, blinded, randomized (1:1), sham controlled study to evaluate the use of the Paradise Ultrasound Renal Denervation System for patients resistant to medical hypertension treatment. This is the first of its kind study, where all patients were placed on a standardized triple combination anti-hypertensive therapy, then tested for sustained hypertension and randomized against a sham control.

Key Take-aways

The Paradise Ultrasound Renal Denervation System significantly lowered blood pressure in patients with resistant hypertension who were randomized and followed for 2 months while on a triple combination therapy, and demonstrated:


Safety

Positive safety profile with no renal artery injury or stenosis through 2 months


efficacy

  • Greater reduction in daytime ambulatory systolic BP than a sham procedure
  • Greater BP lowering effect of RDN vs. sham consistent for 24h, nighttime, and office SBP
  • 2 out of 3 patients observed at least a 5 mmHg drop in ambulatory systolic BP. In those responders, the average drop was 17 mmHg


additive

Additive benefit demonstrated in fully adhered patients on the 3-drug combination therapy:

  • 6 mmHg drop in daytime systolic ABP compared to sham
  • 38% of RDN patients controlled, nearly 2x more than sham

Azizi et al. Lancet. 2021. In press.
Kirtane. ACC 2021.

The Paradise Ultrasound Renal Denervation System significantly lowered blood pressure and demonstrated safety and efficacy in patients with resistant hypertension at 2 months.