TIVUS Renal Denervation for High Blood Pressure
(THRIVE Trial)
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: SoniVie Inc.
Must not be taking: Beta blockers, Anticoagulants, Immunosuppressives, NSAIDs
Disqualifiers: Diabetes, Cardiovascular events, Renal issues, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
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
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.
12345How 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.
26789Eligibility 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
I have signed and understand the consent form.
I am between 22 and 75 years old.
I have a documented history of high blood pressure.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Wash-out
Participants undergo a 4-week wash-out period off antihypertensive medications before the RDN/Sham procedure
4 weeks
Treatment
Participants receive either the TIVUS™ Renal Denervation System treatment or a sham procedure
1 day
1 visit (in-person)
Post-procedure Monitoring
Participants are monitored off antihypertensive medications for 2 months post-procedure
2 months
Medication Reintroduction
Participants with uncontrolled hypertension are put back on antihypertensive medication according to a medication escalation protocol
4 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, with unblinding at 6 months and potential cross-over for sham subjects
6 months
Long-term Follow-up
All subjects treated with TIVUS are followed for a maximum of 36 months post-procedure
36 months
Participant Groups
The THRIVE study tests the TIVUS Renal Denervation System against a sham (fake) procedure in lowering blood pressure. Participants will stop taking their usual hypertension drugs during the trial to see if this new system can effectively reduce their blood pressure without medication.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TIVUS™ Renal Denervation SystemExperimental Treatment1 Intervention
Following angiogram, subjects found anatomically eligible and randomized to the renal denervation arm will be treated with the TIVUS™ Renal Denervation System.
Group II: ShamPlacebo Group1 Intervention
For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Honor Health Research InstitueScottsdale, AZ
Cardiology Associates Research GroupJonesboro, AR
Arkansas Heart HospitalLittle Rock, AR
Cedar-Sinai Medical CenterLos Angeles, CA
More Trial Locations
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Who Is Running the Clinical Trial?
SoniVie Inc.Lead Sponsor
NAMSACollaborator
European Cardiovascular Research CenterCollaborator
References
Catheter-based renal denervation for resistant hypertension: Twenty-four month results of the EnligHTN I first-in-human study using a multi-electrode ablation system. [2022]Long term safety and efficacy data of multi-electrode ablation system for renal denervation (RDN) in patients with drug resistant hypertension (dRHT) are limited.
The rise, fall, and possible resurrection of renal denervation. [2018]Renal denervation has a chequered history. Dramatic reductions in blood pressure after denervation of the renal arteries were observed in early trials, but later trials in which denervation was tested against a sham procedure produced neutral results. Although a sound pathophysiological basis exists for interruption of the renal sympathetic nervous system as a treatment for hypertension, trial data to date are insufficient to support renal denervation as an established clinical therapy. In this Perspectives article, we summarize the currently available trial data, device development, and trials in progress, and provide recommendations for future trial design.
Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. [2022]To evaluate the safety and efficacy of the balloon-based bipolar Vessix Renal Denervation System in treating patients with resistant hypertension.
Current Status of Renal Denervation in Hypertension. [2018]Over the past 7 years, prospective cohorts and small randomized controlled studies showed that renal denervation therapy (RDN) in patients with resistant hypertension is safe but associated with variable effects on BP which are not substantially better than medical therapy alone. The failure of the most rigorously designed randomized sham-control study, SYMPLICITY HTN-3, to meet the efficacy endpoints has raised several methodological concerns. However, recently reported studies and ongoing trials with improved procedural characteristics, identification of patients with true treatment-resistant hypertension on appropriate antihypertensive regimens further explore potential benefits of RDN. The scope of this review is to summarize evidence from currently completed studies on RDN and discuss future perspectives of RDN therapy in patients with resistant hypertension.
Review and meta-analysis of renal artery damage following percutaneous renal denervation with radiofrequency renal artery ablation. [2021]We aimed to estimate the rate of renal artery adverse events following renal denervation with the most commonly applied radiofrequency catheter system based on a comprehensive review of published reports.
An Open-label, Single-arm, Multicenter Feasibility Study Evaluating the Safety of Catheter-based Renal Denervation with DENEX™ in Patients with Uncontrolled Hypertension on Standard Medical Therapy. [2021]DENEX™ is a novel renal sympathetic denervation (RDN) system that is equipped with 3 electrodes that deliver radiofrequency energy to the renal nerves along renal arteries. The purpose of this study was to evaluate the safety and efficacy of RDN with DENEX™ in resistant hypertension.
Safety and performance of the second generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension. [2022]Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and performance of the second generation EnligHTN™ Renal Denervation System.
Italian Society of Arterial Hypertension (SIIA) Position Paper on the Role of Renal Denervation in the Management of the Difficult-to-Treat Hypertensive Patient. [2020]Renal denervation is a device-based procedure for hypertension for which safety and efficacy has been demonstrated. At present, its clinical use is still matter of debate, despite the most recent clinical trials have shown promising results with new-generation devices in various hypertensive populations. This position paper was deemed necessary by the Italian Society of Arterial Hypertension, in order to provide indications about the applications of renal denervation in the clinical setting. A state-of-the art review of the literature, focusing on safety and efficacy data, is provided. Furthermore, based on current evidence and expert consensus, clinical profiles of possible candidates for renal denervation are proposed. The selection process should take into account not only blood pressure values, global cardiovascular risk profile, but also drug adherence and tolerability and patient preferences. This position paper also defines minimum requirements for renal denervation selection centers and a flowchart for the difficult-to-treat hypertensive patient. Further studies are needed to support these preliminary indications, which are based on expert-consensus only.
Favorable effect of renal denervation on elevated renal vascular resistance in patients with resistant hypertension and type 2 diabetes mellitus. [2023]To assess the effect of renal denervation (RDN) on renal vascular resistance and renal function in patients with drug-resistant hypertension (HTN) and type 2 diabetes mellitus (T2DM).