NCT01385176

Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)

Neural Cardiac Therapy for Heart Failure Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.

Detailed description

The objectives of this study are to assess the impact of right vagal nerve stimulation on left ventricular remodeling, functional capacity, quality of life, and other measures in heart failure patients over a 6-month period. In addition, the study will assess the safety of the NECTAR-HF study system over an 18-month period.

Conditions

• Heart Failure
• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	Implant of investigational device system	Vagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region.
PROCEDURE	Titration during the randomization phase	Amplitude of the chronically delivered vagus nerve stimulation in the experimental arm was adjusted to the highest tolerable by patient value. No chronically delivered vagus nerve stimulation in the control arm during the randomization phase.
PROCEDURE	Titration after the randomization phase	Amplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study.
DIAGNOSTIC_TEST	Blood Draw	Blood draw before implant and 6 months after implant at the end of the randomization phase.

Timeline

• Start date: 2011-09-21
• Primary completion: 2014-05-01
• Completion: 2026-06-30
• First posted: 2011-06-30
• Last updated: 2026-03-24
• Results posted: 2020-01-06

Locations

21 sites across 8 countries: Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom