Multicenter post-market study to assess and im-prove patient response to CRT therapy with the amy-card 01C system(MAP-CRT)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 38

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

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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the LVESV, assessed by echo examination at 6-12 months post<br /><br>CRT implan-tation. The cut-off parameter for response/non-response is LVESV<br /><br>reduction of 15% or more versus baseline.<br /><br><br /><br>LV size should be assessed on a 2D echo examination by calculating volumes<br /><br>using the biplane method of disks summation technique. In sites and operators<br /><br>with experience in 3D echo, 3D measurement and reporting of LV volumes is<br /><br>recommended when feasible depending on image quality, see further details in<br /><br>the recommendations of the American Society of Echocardiog-raphy and the<br /><br>European Association of Cardiovascular Imaging (#23 in the reference list).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint is a composite clinical score of death and HF<br /><br>hospitalization at 12 months<br /><br>post-implantation.<br /><br><br /><br>Note:<br /><br>The LVESV parameter will assess patient improvement at the 6-12 months<br /><br>follow-up-visit. However, to accommodate variance in the timing of the<br /><br>follow-up-visit, deaths and HF hospitalizations will be taken into account<br /><br>until 12 months after the implantation. </p><br>