AV-Node Stimulation to influence heart failure markers in Acutely Decompensated Heart Failure patients
- Conditions
- acutely decompensated heart failureheart failure10019280
- Registration Number
- NL-OMON45274
- Lead Sponsor
- Medtronic B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
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 <=35% and QRS>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 < 90% on room air prior to treatment;
2) NYHA class III or IV at enrollment;
3) Age > 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 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 < 18 years;
4) Patient not disposed to sign the Informed Consent;
5) 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.
6) Subject is a breastfeeding woman;
7) Participation in other studies which could potentially conflict with this study;
8) 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.;Exclusion criteria for AVNS phase;1) Patients in cardiogenic shock. Cardiogenic shock is usually characterized by reduced blood pressure (BP) (< 90 mmHg) or a drop of mean arterial pressure > 30 mmHg and/or low urine output < 0.05 ml/kg/h with a pulse rate > 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Measurement of NT-proBNP plasma concentration will be performed by using a<br /><br>venous sample extracted 5 minutes before time 0 and after 24 hours from time 0<br /><br>in both groups. This is a marker of heart failure.</p><br>
- Secondary Outcome Measures
Name Time Method