NCT00957073

Rheos System for the Treatment of HFpEF Heart Failure

Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implantable Pulse Generator (IPG) replacements.

Detailed description

The initial trial design randomized subjects in a 2:1 ratio to receive a Rheos system plus medical management (Device Arm) or to receive medical management alone (Medical Management Arm). On March 24, 2011, the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed; 19 subjects had been randomized, 10 device and 9 medical management. Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10 device subjects continued in the study. Long-term follow-up visits occurred at 15 and 18 months post-randomization; visits occur semi-annually until study closure. The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Rheos® system	Implant procedure

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-10-01
• Completion: 2021-04-01
• First posted: 2009-08-12
• Last updated: 2021-04-08

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated device study