Renal Denervation for High Blood Pressure
(REDUCED Trial)
Trial Summary
What is the purpose of this trial?
This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. The trial requires that you maintain your anti-hypertensive medication regimen for at least 3 months.
What data supports the effectiveness of the TIVUS™ System treatment for high blood pressure?
Research on renal denervation, a treatment that uses energy to disrupt nerves in the kidneys, shows it can lower blood pressure in patients with resistant hypertension (high blood pressure that doesn't respond to medication). Studies like the DENERHTN trial and others have confirmed its effectiveness when combined with other treatments.12345
Is renal denervation safe for humans?
Studies on renal denervation, including those using different systems like radiofrequency and balloon catheters, have been conducted to assess safety. While some trials report limited long-term safety data, others focus on evaluating adverse events related to the procedure, indicating ongoing research to ensure its safety in humans.26789
How does the TIVUS™ System treatment for high blood pressure differ from other treatments?
The TIVUS™ System is unique because it uses ultrasound energy to target the renal nerves, which may help lower blood pressure by disrupting nerve signals that contribute to hypertension. This approach is different from traditional drug therapies and other renal denervation systems that typically use radiofrequency energy.36101112
Research Team
Ajay Kirtane, MD
Principal Investigator
Columbia University/NYPH
Eligibility Criteria
This trial is for adults aged 18-80 with stage 2 hypertension, who have high blood pressure despite taking medication. Participants should be willing to maintain their current medication regimen and comply with study procedures. Pregnant women, individuals planning major surgeries, those on certain anticoagulants or with severe kidney issues are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo renal denervation using the TIVUS™ System
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for changes in blood pressure and renal function
Treatment Details
Interventions
- TIVUS™ System
Find a Clinic Near You
Who Is Running the Clinical Trial?
SoniVie Inc.
Lead Sponsor