THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension

Conditions

• Hypertension

Eligibility Criteria

Sex

ALL

Age

22 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• TIVUS™ Renal Denervation System — DEVICE
  Renal artery catheterization procedure used to denervate the renal sympathetic nerves in the perivascular space using ultrasound energy.
• Sham — OTHER
  For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.

Study Details

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 uncontrolled hypertension (HTN) receiving 0 - 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 1 - 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

Key Dates

Start date

Oct 3, 2024

Status verified

May 2026

Primary completion

Mar 31, 2027

Completion

Aug 15, 2028

Study Design

Enrollment

261 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: TIVUS™ Renal Denervation System
  Following angiogram, subjects found anatomically eligible and randomized to the renal denervation arm will be treated with the TIVUS™ Renal Denervation System.
• Sham Comparator: Sham
  For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.

Primary Outcome Measure

Reduction in average daytime ambulatory systolic BP [ Time Frame: From baseline to 2 months post-procedure ]

Central Contacts

• Lisa Melchior
  651-324-4931
  [email protected]
• Janelle Noble
  612-598-4368
  [email protected]

Locations (33)

Find similar trials in Birmingham, AL

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