decompensatio cordis heart failure
Conditions
Interventions
The VITARIA System lead will be implanted on the right cervical vagus nerve.
After the lead and IPG are connected, the surgical/cardiovascular team will
perform standard diagnostic testing to ensure
frequency = 5 Hz
pulse width = 130 µs
duty cycle =
14 seconds on, 66 seconds off
Sponsors
LivaNova USA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 4 Currently in sinus rhythm (extrasystoles are allowed; CRT or CRT-D recipients who have been receiving CRT for at least 6 months, and ICD and pacemaker recipients, may enter the study; paroxysmal and persistent atrial fibrillation are allowed if the patient is currently in sinus rhythm5. Guideline Directed Medical Therapy for at least 4 weeks6. Stable symptomatic NYHA III; or II with a HF hospitalization within the previous 12 months7. Left ventricular ejection fraction (LVEF) 800 pg/mL as determined by the core-laboratory, as long as the patient reports having experienced no signs or symptoms of atrium fibrilation during the 3 days preceding the NT-proBNP measurements . 10. Baseline 6 Minute Walk Test (6MWT) between 150 and 450 meters
Exclusion criteria
Exclusion criteria: 1. Refractory symptomatic hypotension (SBP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be a composite of cardiovascular mortality or heart failure hospitalization, based on time to first event after randomization, as adjudicated by an independent Clinical Events Committee (CEC). The primary safety endpoint will consist of the event-free rate, through 90 days after VITARIA implantation, from all VITARIA system-related and VITARIA implantation-related serious adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| If the primary efficacy and primary safety endpoints achieve statistical significance, treatment groups will be compared on the following key secondary endpoints: * Mean change in the quality of life (KCCQ) from baseline to 9 months * Proportion of subjects who have an improvement in NYHA class from baseline to 9 months * Rate of unplanned HF hospitalization equivalents from baseline If all 3 key secondary endpoints are met, treatment groups will be compared on the following endpoint: - Mean change in LVEF from baseline to 9 months Treatment groups will also be compared on the following secondary endpoints: * Mean change in 6-minute walk distance from baseline to 9 months * Mean change in LVEDD, LVESD, and LVESVi from baseline to 9 months * Rate of hospitalization-free days from baseline * Change in NYHA class from baseline to 9 months * All-cause mortality | — |
Countries
Netherlands
Outcome results
None listed