acutely decompensated heart failure heart failure
Conditions
Interventions
Training phase procedure
In the training phase the procedure will coincide with a cardiac device
implantation. Subjects will undergo a standard implant procedure with the
exception of atrial lead p
- acutely decompensated heart failure
- AV-node stimulation
- parasympathetic nerves
- vagal branch stimulation
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria of training phase;Patients are eligible to be enrolled for the lead placement training procedure if one of the following criteria is met: 1) Indication for CRT implant according to current guidelines (Heart Failure, NYHA III-IV class, symptomatic despite optimal stable medical therapy, left ventricular (LV) ejection fraction 120ms); 2) Indication for ICD implant according to current guidelines; 3) Indication for pacemaker implant according to current guidelines.;Inclusion criteria of AVNS phase;1) Acutely decompensated HF as indicated by one of the symptoms such as - shortness of breath (dyspnea) - oedema (verified by chest X-ray) accompanied by severe respiratory distress, with crackles over the lungs and orthopnea, with Oxygen (O2) saturation usually 18 years; 4) Subject provides informed consent; 5) Subject is willing and able to comply with the study procedures; 6) Hospitalization for acute decompensated HF did start within the last 24 hours.
Exclusion criteria
Exclusion criteria: Exclusion criteria for training phase;1) Advanced AV block (II-III degree AV block); 2) Potential damage to cardiac nerves involved due to one of the following - ablation; - valvular surgery; - cardiac transplantation; - aortic surgery; 3) Age 30 mmHg and/or low urine output 60 beats per minute (bpm) with or without evidence of organ congestion; 2) Heart rate below 50 bpm during sleep at night time and 60 bpm at day time; 3) Patient already implanted with a pacemaker or implantable cardioverter defibrillator; 4) Patient already implanted with a neurostimulation device; 5) Myocardial infarction, as defined by clinical symptoms and an increased cardiac Troponin T or I with a significant dynamic increment in 2 subsequent measurements [1], which occurred in the last 30 days, causing heart failure (an increased value for cardiac troponin is defined as a measurement exceeding the 99th percentile of a normal reference population [URL = upper reference limit]); 6) Heart failure due to congenital disease; 7) Hypertrophic obstructive cardiomyopathy; 8) Infiltrative cardiomyopathy; 9) Vasovagal syncope; 10) Advanced AV block (II-III degree AV block); 11) Congenital or acquired long QT syndrome; 12) Potential damage to cardiac nerves involved due to one of the following - ablation; - valvular surgery; - cardiac transplantation; - aortic surgery; 13) Subject is a pregnant woman or woman of childbearing potential not on adequate birth control: only woman with a highly effective method of contraception [oral contraception or intra-uterine device] or sterile woman can be enrolled. 14) Subject is a breastfeeding woman; 15) Participation in other studies which could potentially conflict with this study; 16) Diabetes mellitus with measured hemoglobin A1c > 8% in the past 60 days; 17) Untreated hypo- or hyperthyroidism; 18) Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of NT-proBNP plasma concentration will be performed by using a venous sample extracted 5 minutes before time 0 and after 24 hours from time 0 in both groups. This is a marker of heart failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Local norepinephrine Norepinephrine is a marker of autonomic balance. For each patient in the AVNS treatment group, local norepinephrine and epinephrine measurement will be performed immediately before starting the AVNS treatment (- 5 minutes) and after 30 minutes from the beginning of AVNS treatment by means of coronary arterial blood samples. - Inflammatory status Measurements of inflammatory markers TNF-alfa, IL-6 that will be performed by using a venous sample extracted 5 minutes before time 0 (see definition at primary objective) and at 1, 6 and 24 hours after time 0 in both groups. - Preventing heart failure deterioration Measurements of heart failure markers, Troponin-T and NT-proBNP that will be performed by using a venous sample extracted 5 minutes before time 0 (see definition at primary objective) and at 1, 6 and 24 hours after time 0 in both groups. - Kidney function Kidney function is a marker of heart failure. Measurements of kidney function markers, aldosterone and renin will be performed by using venous samples extracted 5 minutes before time 0 (see definition at primary objective) and at 1, 6 and 24 hours after time 0 in both groups. Measurement of diuresis (ml/24 hours) per 40 mg furosemide at 24 hours will be also performed in both groups. - Safety of the AVNS procedure a. Safety evaluation in term of percentage and rate of adverse events and serious adverse events related to AVNS and related to atrial lead placement at AVNS position at implant and at the follow-up; b. Number of episodes and burden of atrial tachycardia(AT), atrial fibrillation(AF), ventricular tachycardia (VT) and ventricular fibrillation (VF) in both the AVNS and the control group for 24 hours after time 0; c. Description of ADHF symptoms in term of percentage of patients reporting specific symptoms in both groups for 24 hours after time 0. - Data gathering for further possible applications of AVNS Evaluation of possible further applications of A | — |
Countries
Germany, Netherlands
Outcome results
None listed