TIVUS Renal Denervation for High Blood Pressure
(THRIVE Trial)
Trial Summary
Will I have to stop taking my current medications?
Yes, participants will need to stop taking their anti-hypertensive medications for a 4-week period before the procedure and remain off them for 2 months after the procedure.
Is the TIVUS Renal Denervation System safe for humans?
Renal denervation, including systems like TIVUS, has been studied for safety in treating high blood pressure, and research suggests it is generally safe, though its effectiveness varies. Some studies have shown it does not cause significant harm to the renal arteries, but results on its benefits compared to standard treatments are mixed.12345
How does the TIVUS Renal Denervation treatment for high blood pressure differ from other treatments?
TIVUS Renal Denervation is a unique treatment for high blood pressure that involves a procedure called renal denervation, which targets the nerves in the kidneys using a catheter-based system. Unlike traditional medications, this treatment uses radiofrequency energy to disrupt nerve activity, potentially reducing blood pressure in patients who do not respond well to standard drug therapies.26789
What is the purpose of this trial?
The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in:1. subjects with hypertension (HTN) receiving up to 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN/Sham procedure and during 2 months after procedure.2. subjects with controlled hypertension receiving up to 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after the procedure
Research Team
Ajay Kirtane, MD
Principal Investigator
Columbia University
Michel Azizi, MD
Principal Investigator
George Pompidou Hospital
Felix Mahfoud, MD
Principal Investigator
University of Basel
Eligibility Criteria
This trial is for adults aged 22-75 with hypertension, who are on up to two blood pressure medications and willing to stop these meds for a washout period before and after the procedure. They must have controlled BP (<140/90 mmHg), be able to follow study procedures, undergo conscious sedation, and have suitable renal anatomy.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Wash-out
Participants undergo a 4-week wash-out period off antihypertensive medications before the RDN/Sham procedure
Treatment
Participants receive either the TIVUS™ Renal Denervation System treatment or a sham procedure
Post-procedure Monitoring
Participants are monitored off antihypertensive medications for 2 months post-procedure
Medication Reintroduction
Participants with uncontrolled hypertension are put back on antihypertensive medication according to a medication escalation protocol
Follow-up
Participants are monitored for safety and effectiveness after treatment, with unblinding at 6 months and potential cross-over for sham subjects
Long-term Follow-up
All subjects treated with TIVUS are followed for a maximum of 36 months post-procedure
Treatment Details
Interventions
- TIVUS™ Renal Denervation System
Find a Clinic Near You
Who Is Running the Clinical Trial?
SoniVie Inc.
Lead Sponsor
NAMSA
Collaborator
European Cardiovascular Research Center
Collaborator