heart failure NYHA class III or IV
Conditions
Interventions
all patients will undergo standard implantation of a CRT-device. During
procedure the effect of CRT will be evaluated on-table by means of measurement
of LV dP/dtmax according to the standard hospit
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The Class I ACC/AHA/HRS 2008 recommendations for CRT in patients with severe systolic heart failure are used as inclusion criteria. This means that patients who have a LVEF less than or equal to 35%, a QRS duration greater than or equal to 0.12 seconds with sinus rhythm and NYHA functional class III or ambulatory class IV heart failure symptoms despite optimal recommended medical therapy will be included. Optimal recommended medical therapy is defined as the use of angiotensin-converting-enzyme inhibitors or angiotensin-II-receptor blockers and beta-blockers (unless they are not tolerated or contra-indicated). Although a Class IIa recommendation, patients with atrial fibrillation will also be included.
Exclusion criteria
Exclusion criteria: In case of following criteria patient will be excluded from our study: episode of acute heart failure within 3 months prior to inclusion, change in dosage of beta-blocker, angiotensin-converting enzyme inhibitor or angiotensin-II receptor blocker within 3 months prior to inclusion; unstable angina pectoris, acute myocardial infarction, percutaneous intervention or coronary bypass surgery within 3 months prior to inclusion; chronic atrial arrhythmias other than atrial fibrillation; any mechanical or biological valve prosthesis, atrial septal defect, right-to-left shunt; severe pulmonary hypertension, uncontrolled arterial hypertension; known allergy to sulphur hexafluoride, end-stage renal or hepatic disease; pregnancy or child-bearing potential without the use of any birth control measurements; inability to provide a written informed consent; general contra-indications to magnetic resonance imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in LV dP/dt max during left ventricular endocardial pacing OR during simulated exercise with dobutamine (depening on subgroup) | — |
Secondary
| Measure | Time frame |
|---|---|
| change in NYHA functional class, quality of life determined by Minnesota Living With Heart Failure Questionnaire, 6-minutes walking test, change in left ventricular ejection fraction, change in left ventricular end-systolic and diastolic diameter and volume. | — |
Countries
Netherlands
Outcome results
None listed