THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
NCT Number: NCT06559891
Acronym: THRIVE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Interventions: DEVICE: TIVUS™ Renal Denervation System|OTHER: Sham
Sponsor: SoniVie Inc.
Collaborators: NAMSA|European Cardiovascular Research Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 261
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2028-08-15

Summary:
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

Primary Outcome Measures: Reduction in average daytime ambulatory systolic BP, Primary outcome, From baseline to 2 months post-procedure|Subject level composite of the incidence of Major Adverse Events (MAE), Safety outcome, From Baseline to 30 day and 6 months post procedure
Secondary Outcome Measures: Reduction in average 24-hr ambulatory systolic BP, Secondary outcome, From baseline to 2 Months post procedure|Reduction in average home systolic BP, Secondary outcome, From baseline to 2 Months post procedure|Reduction in average office systolic BP, Secondary outcome, From baseline to 2 Months post procedure|Reduction in average daytime ambulatory diastolic BP, Secondary outcome, From baseline to 2 Months post procedure|Reduction in average 24-hr ambulatory diastolic BP, Secondary outcome, From baseline to 2 Months post procedure|Reduction in average home diastolic BP, Secondary outcome, From baseline to 2 Months post procedure|Reduction in average office diastolic BP, Secondary outcome, From baseline to 2 Months post procedure|Percentage of subjects with Systolic Blood Pressure (SBP) at target (daytime SBP <135 mmHg; office SBP <140, Secondary outcome, From baseline to 2 and 6 Months post procedure|Percentage of subjects with SBP at target (daytime SBP <135 mmHg; office SBP <140 mmHg) in the absence of. changes in hypertensive medication in each arm, Secondary outcome, From baseline to 2 and 6 Months post procedure|Incidence of ambulatory systolic BP (daytime/24-hr/night-time) reductions of ≥5 mmHg, ≥10 mmHg, and ≥15 mm Hg, Secondary outcome, From baseline to 2, 6, and 12 Months post procedure
Other Outcome Measures: Reduction in average night-time ambulatory systolic/diastolic BP, Observational outcome, From baseline to 2, 6 and 12, Months post procedure|Reduction in average daytime & 24-hr ambulatory systolic BP at 6- and 12-months post procedure., Observational outcome, From baseline to 6 and 12 Months post procedure|Reduction in average daytime & 24-hr ambulatory diastolic BP, Observational outcome, From baseline to 6 and 12 Months post procedure|Reduction in average office systolic BP, Observational outcome, From baseline to 6 and 12 Months post procedure|Reduction in average home systolic/diastolic BP, Observational outcome, From baseline to 1, 3, 4, 5, 6, and 12-Months post procedure|Reduction in office and ambulatory pulse pressure, Observational outcome, From baseline to 2, 6 and 12 Months post procedure|Reduction in office and ambulatory heart rate, Observational outcome, From baseline to 2, 6, and 12 Months post procedure|Antihypertensive medication burden (number of antihypertensive drugs, doses, classes), Observational outcome, From baseline to 2, 6 and 12 Months post procedure|Percentage of subjects meeting escape criteria, Observational outcome, From baseline to 2 Months post procedure|Percentage of subjects requiring initiation of antihypertensive drug therapy, Observational outcome, From baseline to 2 and 6 Months post procedure|Percentage of subjects without any antihypertensive treatment, Observational outcome, From baseline to 6 and 12 Months post procedure|Percentage of subjects requiring initiation of anti-hypertensive drug therapy at any available time points post procedure, Observational outcome, From baseline through completion of study|Change in adherence to medications assessed by urine chemical adherence testing using liquid chromatography with tandem mass spectrometry (LCMSMS), Observational outcome, From baseline to 2, 6, 12, 24 and 36 Months.