NL-OMON55303CompletedNot Applicable
Multicenter post-market study to assess and im-prove patient response to CRT therapy with the amy-card 01C system(MAP-CRT) - CRT study with amycard 01C stystem
EP Solutions SA0 sites38 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •2. Patients who have contraindications to CT scanning: excess body weight (BMI
- •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,
- •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
- •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-
Investigators
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