CRT device
Conditions
Interventions
None listed
Sponsors
EP Solutions SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Appropriately signed and dated informed consent. 2. Age *18 years at time of consent. 3. The presence of a CRT device implanted 6-24 months ago. 4. Patients in Sinus Rhythm or AF with BiV pacing >90%. 5. Patients that fulfilled Class I or Class IIa clinical recommendations per the ESC Guidelines at the time of implantation. 6. Patients have correctly set pacing parameters (interventricular delay) according to the ESC Guidelines (QRS duration, Echo). 7. Patients were reliably diagnosed with the cause of heart failure. 8. Patients had a reliable assessment of the degree of cardiac failure before CRT device implantation and during the follow up period.
Exclusion criteria
Exclusion criteria: 1. Patients with acute diseases or exacerbations of chronic diseases; recent surgery. 2. Patients who have contraindications to CT scanning: excess body weight (BMI >40) recent x-ray examination (CT, interventional procedures under fluoros- copic control), radiation therapy, allergic reactions to iodine, intolerance to X-ray contrast agents, kidney diseases with elevated creatinine levels, (>45) diseases of the thyroid gland with impaired T3 and T4 levels, difficulties for venous access, blood clotting disorders. 3. Contraindications to body surface ECG mapping: recent surgery on the chest, skin diseases, allergic reactions to surface mapping electrodes and medical band-aid. 4. Patients that have undergone AV nodal ablation and/or are pacemaker dependent. 5. Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required documented within a maximum of 7 days prior to procedure for all women of childbearing potential. Documentation of effective contraception is also required for women of childbearing po- tential).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the LVESV, assessed by echo examination at 6-12 months post CRT implan-tation. The cut-off parameter for response/non-response is LVESV reduction of 15% or more versus baseline. LV size should be assessed on a 2D echo examination by calculating volumes using the biplane method of disks summation technique. In sites and operators with experience in 3D echo, 3D measurement and reporting of LV volumes is recommended when feasible depending on image quality, see further details in the recommendations of the American Society of Echocardiog-raphy and the European Association of Cardiovascular Imaging (#23 in the reference list). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is a composite clinical score of death and HF hospitalization at 12 months post-implantation. Note: The LVESV parameter will assess patient improvement at the 6-12 months follow-up-visit. However, to accommodate variance in the timing of the follow-up-visit, deaths and HF hospitalizations will be taken into account until 12 months after the implantation. | — |
Countries
Netherlands
Outcome results
None listed