Ischaemic cardiomyopathy Circulatory System Ischaemic cardiomyopathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. >= 18 years of age 2. Standard indication for CRT-P or CRT-D according to ESC/EHRA guidelines 3. Stable on optimal medical therapy for at least 3 months 4. Ischaemic aetiology 5. Patients with atrial fibrillation can be included
Exclusion criteria
Exclusion criteria: 1. Any contraindication to pacing/implantable cardioverter-defibrillator (ICD) implant 2. Requirement for endocardial pacing 3. Contraindication to magnetic resonance (MR) scanning 4. Claustrophobia 5. Significant renal impairment with estimated glomerular filtration rate (eGFR) < 30 ml/minute 6. Existing pacemaker or ICD system or extraction of a CRT system within the last 6 months 7. Be pregnant or plan to become pregnant over the next 7 months 8. Participation in other studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End systolic volume (ESV) in (ml) measured using a 2D echocardiogram at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. End diastolic volume (ESV) in (ml) measured using a 2D echocardiogram at baseline and 6 months 2. Ejection fraction (%) measured using a 2D echocardiogram at baseline and 6 months 3. Quality of life measured using a Minnesota Living with Heart Failure Questionnaire score at baseline and 6 months 4. Efficacy of device implant measured using clinical composite score at 6 months 5. Class of heart failure measured using NYHA class at baseline and 6 months | — |
Countries
United Kingdom