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

NCT01385176 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-04-29

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Faiez Zannad, M.D. · Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-21
Primary Completion
2014-05-31
Completion
2026-06-30

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01385176 on ClinicalTrials.gov